Tetanus toxoid reduced diphtheria toxoid and acellular pertussis vaccine adsorbed(GlaxoSmithKline Plc)

WESTON, Fla.--(BUSINESS WIRE)-- iLiAD Biotechnologies, LLC (ILiAD), a vaccine company utilizing its B-Tech technology to develop novel vaccines against infectious diseases, today announced a peer-reviewed publication in The Lancet. The published research article summarizes the adult Phase 2b clinical study of BPZE1, the most advanced next generation pertussis vaccine. The multi-center, double-blinded, randomized trial was designed to evaluate mucosal and serum immune responses following vaccination, as well as nasopharyngeal colonization after attenuated challenge. The trial enrolled 300 healthy volunteers ranging from 18 to 50 years old. Participants were randomized to receive either BPZE1 or BOOSTRIX® (tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine) and then challenged three months later with either BPZE1 or placebo and tested for nasal colonization. The manuscript titled “Immunogenicity and safety of BPZE1, an intranasal live attenuated pertussis vaccine, versus tetanus–diphtheria– acellular pertussis vaccine: a randomised, double-blind, phase 2b trial” was published in The Lancet on March 10, 2023. The publication can be found here (link). Key findings from the trial are summarized below: BPZE1 was well tolerated with most participants experiencing no or mild systemic, nasal or respiratory symptoms of short duration, similar to that observed with Boostrix and placebo, including no vaccine-related serious adverse events. A single vaccination with BPZE1 prevented colonization in 90% of participants after challenge 3 months later. BPZE1 was differentiated in its ability to induce broad mucosal immunity with sustained durability to the end of the study (9 months). Boostrix induced systemic immunity as expected, but was unable to substantially prevent colonizing infection or induce broad mucosal immunity as seen with BPZE1. “In contrast to Boostrix, BPZE1 demonstrated both protection against attenuated Bordetella pertussis colonization and induction of pertussis-specific mucosal immune responses. In addition, BPZE1 demonstrated a favorable safety pro this study. These data support the continued development of BPZE1,” said Stephanie Noviello M.D., ILiAD Chief Medical Officer. Keith Rubin MD, ILiAD founder and CEO commented, “The publication of these data in The Lancet, one of the most respected peer-reviewed medical journals in the world, is consistent with the quality of our Phase 2b study and the potential major public health impact of BPZE1. These data add to the robust body of evidence supporting the potential of BPZE1 to address the limitations of current pertussis vaccines and to greatly reduce morbidity and mortality due to Bordetella pertussis on a global scale.” BPZE1 was developed in the lab of Camille Locht, PhD, at the Institut Pasteur de Lille (IPL) and French National Institute of Health and Medical research ( ) and is designed to overcome deficiencies of current pertussis vaccines. About Pertussis Pertussis (whooping cough) is a life-threatening disease caused by the highly contagious respiratory bacterium, Bordetella pertussis. According to U.S. Centers for Disease Control and Prevention, pertussis affects approximately 16 million people each year globally, accounting for nearly 200,000 deaths. There has been an overall increase in reported pertussis cases since the early 1980s. Pertussis is highly contagious, and an infected person can transmit B. pertussis to as many as 15 other people. Pertussis can lead to serious illness in people of all ages and can be life-threatening in young infants. About BPZE1 BPZE1 is the only next generation live-attenuated intranasal pertussis vaccine in advanced clinical trials designed to protect against Bordetella pertussis nasal infection (colonization) and active disease through the induction of broad and sustained mucosal and systemic immunity. BPZE1 is currently being developed as a booster vaccine in children, adolescents and adults with future development investigating its application as a primary vaccination in infants. About ILiAD Biotechnologies, LLC ILiAD Biotechnologies is utilizing its B-Tech technology to develop next generation vaccines to prevent infectious diseases and improve lives. Its lead candidate, BPZE1, is the most advanced next generation vaccine for immunization against pertussis (whooping cough), a potentially lethal disease caused by Bordetella pertussis. For further information, please visit or follow us on Twitter. "Safe Harbor" Statement under the Private Securities Litigation Reform Act of 1995. In addition to historical facts or statements of current, this press release may contain forward-looking statements. Forward-looking statements provide ILiAD's current expectations or forecasts of future events. These may include statements regarding anticipated development of potential products, interpretation of clinical results, prospects for regulatory approval, outsourcing trends in the pharmaceutical industry, levels of industry research and development spending, rapid technological change, risks associated with acquisitions and investments, risks associated directly with BPZE technologies including but not limited to uncertainties of product development, and uncertainties of clinical development, dependence on third parties, competition, protection of patents and proprietary technology, potential for infringement and other statements regarding matters that are not historical fact. Some of these forward looking statements may be identified by use of words in the statements such as "estimate," "intend," or other words and terms of similar meaning. Statements in this release are not guarantees of future performance and involve certain risks, uncertainties and assumptions, which are difficult to predict. Therefore actual outcomes and results may differ materially from what is expressed in such forward-looking statements. ILiAD cautions investors not to place reliance on the forward-looking statements contained in this press release. These statements speak only as of the date of this release and ILiAD undertakes no obligations to update or review these statements, except as may be required by law.

Welcome back to Endpoints Weekly, your review of the week’s top biopharma headlines. Want this in your inbox every Saturday morning? Current Endpoints readers can visit their reader profile to add Endpoints Weekly. New to Endpoints? Sign up here . Many thanks to all those who turned up at the EUBIO event in London this week — the whole team is now basking in the positive feedback we got and the photos are giving me FOMO. Endpoints is looking to bring these in-person gatherings to many more corners of the world. Stay tuned. BIO in tumult as CEO abruptly exits After a short, rocky two-year tenure highlighted by an event-killing pandemic, cutbacks and new pricing legislation widely viewed in biotech as a calamity, BIO CEO Michelle McMurry-Heath is on the way out. She resigned just a couple days after the news broke that she had gone on leave . So far, there has been little clear explanation for what’s come to a head at BIO, with the group declining to engage in reports of internal disputes. Longtime biotech exec Rachel King will be taking her position until they can find a full-time replacement. Some good PhIII news Merck is now one step closer to fulfilling the potential it saw in sotatercept when it wagered $11.5 billion to acquire Acceleron late last year. As promised, it unveiled topline data from the pivotal Phase III STELLAR trial in pulmonary arterial hypertension, which it said met the primary endpoint — with a “profound” impact on a 6-minute walk distance — as well as all but one of the nine secondary endpoints. Data issues still plague Novartis’ gene therapy Novartis’ blockbuster gene therapy Zolgensma has proven to be a major success story as a spinal muscular atrophy treatment. But last week, Nature Biotechnology surfaced a new flaw in the therapy’s earliest phase of development, and despite the authors’ objections, the journal retracted an article from February 2010 noting “multiple inaccuracies in the reported mouse lifespans and in the animal inclusions and exclusions.” Hot targets for M&A? With the number of biopharma acquisitions in 2022 so far falling below recent years, the investment bank SVB Securities put out predictions for where there may be some action in the near term. Noting “broad appetite for M&A and BD” as well as gigantic cash balances, the analysts break down what they see as hot spaces and attractive acquisition targets . Novartis, GSK cut down global footprint At least two Big Pharma players are scaling down their presence globally. GSK is shuttering commercial operations in Kenya and tapping third parties to take over distribution, a move that will impact a number of jobs. With the spinout of Haleon this summer, GSK no longer owns any manufacturing sites in Kenya. Over at Novartis , weeks after CEO Vas Narasimhan unveiled a “US-first” strategy, the company revealed plans to cut around 400 jobs at its Dublin campus by the end of 2024. CELL/GENE TX Can a new gene editing technology out of David Liu’s Broad Institute lab break the spell on a record-low IPO season? Prime Medicine is putting it to the test by setting the terms for an 8.9 million-share offering at a range of $16 to $18. At the midpoint, the preclinical startup would raise $151 million and be worth $1.7 billion . Almost a year after Immatics first took the wraps off preliminary data for its top TCR cell therapy, the biotech says the drug continues to live up to expectations. At the optimal dose — complete with improved manufacturing and study design — the confirmed objective response rate was 80% , which, if sustained, would mark a landmark success for the quest to develop cell therapies for solid tumors. Sangamo is continuing to tick off benchmarks on its Fabry gene therapy. The biotech posted the latest update on its gene therapy for the rare X-linked condition in which patients have a mutation in the gene that codes an enzyme responsible for breaking down fats and sugar. Much of the data look similar to Sangamo’s previous update, suggesting the drug is working as intended . The gene editing biotech Metagenomi has been on a roll for the past few years. Now it’s taking the next step and opening a GMP manufacturing facility on its 50,000-square-foot campus in Emeryville, CA. The facility, which will have two clean rooms and a modular design, will aim to produce the biotech’s gene editing tools as well as scale up the production of nucleases for either partnered or in-house therapeutic programs DEALS Merck may be the third-largest pharma R&D spender in 2021, but that doesn’t stop it from enlisting outside help in funding its mid-stage schizophrenia program. It’s teaming up with Royalty Pharma in a deal that gives Merck $50 million for the ongoing Phase IIb of MK-8189 , which is being studied as a treatment for hallucinations, psychosis and other positive symptoms — and more if it moves into Phase III. Meanwhile, after nearly six years of working together, Merck and Moderna are taking the next step in their cancer vaccine partnership, with the pharma giant opting into a deal to “jointly develop and commercialize” one of Moderna’s personalized cancer shots in combination with the blockbuster drug Keytruda . The option triggers a $250 million payment. After getting bought out before it could jump onto Nasdaq last August, Vividion — Bayer’s preclinical “arms-length” subsidiary — is betting on a relatively unknown North Carolina upstar t. The initial focus concerns four targets, but the five-year deal with Tavros Therapeutics could balloon by another five targets, which would more than double the terms from $430.5 million in milestones to a whopping $912 million. Either way, Tavros gets $17.5 million upfront. The computational chemistry experts at Nimbus have always taken pride in selecting compelling targets and deploying a structure-based approach to drug them. Eli Lilly is now swooping in to partner on one such target, promising up to $496 million for Nimbus to come up with isoform-selective small molecule activators of AMPK to treat a slate of metabolic disorders. BridgeBio’s $2.4 billion partnership with Helsinn took a big hit as the Swiss family group decided to pull infigratinib — approved as Truseltiq in the US for a type of bile duct cancer — from the market, citing business reasons. While the decision doesn’t affect a separate rare disease program at BridgeBio, it does put an end to a Phase III study and changes LianBio’s plans in China. After laying off the majority of its employees and selling off its lead program (which failed two studies in blood disorders), Imara decided the best option it had to maximize shareholder value was to reverse merge with a well-financed company focused on precision oncology. Enliven Therapeutics , which was seeded by OrbiMed and 5AM Ventures , will live on with $300 million in cash to fund its clinical endeavors. In a twist of events, PureTech and Nektar said the media frenzy around their merger talks has pushed them to call things off for now . Its recent disclosure that the companies have exchanged non-binding proposals about a possible combination, PureTech said, created the “impression that discussions were more advanced than they were.” As a result, they terminated the talks. Merck wants in on the biomanufacturing revolution. In a new deal that can be worth up to $144 million , it’s linking arms with Ginkgo Bioworks to help boost active pharmaceutical ingredient production through the use of enzymes. The synthetic biology player will develop a strain of biocatalysts that can be used in chemical synthesis for the production of APIs. Closing out the final chapter of its winding 16-year history, Zosano Pharma sold all of its remaining asset s as part of its bankruptcy proceedings — including the intradermal drug delivery system the company was built on. Emergex Vaccines , an infectious disease player working out of Abingdon, UK, is getting it all: the microneedle array patch tech, intellectual property, license agreements as well as specialized manufacturing equipment. AI Sequencing behemoth Illumina is making another push into drug development even as it continues to fight for its merger with Grail , an early-detection cancer test company. Its new pact with AstraZeneca will see it pitch in two AI tools to aid the search for new, promising drug targets and figure out which patient subgroups will benefit most from certain experimental treatments. Terray , a small California biotech that emerged from stealth last year to go after drug discovery’s “data problem,” took the wraps off its first public partnership — and it’s with Calico Life Sciences , the Google -backed anti-aging biotech co-founded by industry legend, billionaire and current CEO Art Levinson , the former head over at Genentech and current chairman at Apple . R&D Pfizer won’t be the only drugmaker to file an RSV vaccine with the FDA this year. GSK — another frontrunner in the long race to develop a shot that can protect the elderly from respiratory syncytial virus infections — is out with what CSO Tony Wood calls “truly exceptional” Phase III results with an overall efficacy of 82.6%, opening the door to regulatory submissions in 2022. Earlier this year, Lululemon’s founder Chip Wilson went public with his rare disease diagnosis of facioscapulohumeral muscular dystrophy type 2, and committed $100 million to find a cure. Now, up to $10 million of that commitment is going to Vita Therapeutics , a Baltimore-based cell therapy biotech, and Vita will be adding a discovery-phase FSHD cell therapy to its pipeline. The money from Solve FSHD is part of Vita’s $31 million Series B. Roche vet Jean-Jacques Garaud co-founded Inotrem in 2013 with a two-pronged approach to target the inflammatory pathway called TREM-1. In a Phase IIb trial with 361 patients who experienced septic shock, the drug it made helped a subgroup with high soluble TREM-1 levels but didn’t differentiate itself from standard of care for the overall group. Florida-based Relmada Therapeutics reported a Phase III fail for its lead compound, REL-1017 , which it had hoped to be a rapid-acting antidepressant, in major depressive disorder, noting the program did not separate from placebo after 28 days in a depression rating scale measuring severe episodes. The company blamed an unforeseen spike in the placebo responses. Shares cratered. Having dedicated themselves to developing treatments for neurological conditions of the ear, a streak of clinical setbacks for their hearing loss treatments is forcing Otonomy to explore strategic options . In a prepared statement, CEO David Weber noted the “challenging financing environment” as part of what led to the decision. A biopharma that markets an ADHD medication, and sells a portfolio of over-the-counter consumer health products on Amazon and elsewhere, has decided to scrap all work on clinical-stage assets. Aytu BioPharma will do away with a global Phase III trial that had begun just three months ago, a move that it says will save about $20 million. As J&J’s Janssen works to expand the use of the IL-23 drug Tremfya , its latest data are backing an expansion to ulcerative colitis. Phase IIa results suggest Tremfya, briefly in combination with golimumab , spurred a clinical remission rate of 47.9% at week 38, much higher than golimumab alone. Evofem , which has an approved non-hormonal birth control gel, had hoped it would be at the FDA’s doorsteps in early 2023 to request a label expansion into STI prevention. But those ambitions were squashed as its gel, marketed as Phexxi for contraceptive use, failed a Phase III study testing it as a way to stop the spread of chlamydia and gonorrhea infection. DICE Therapeutics is now moving forward on the next stage of clinical development for its IL-17 candidate, on the heels of touting a Phase I win. Topline data from a trial enrolling 104 participants — a mix of healthy volunteers and psoriasis patients — burnished the concept behind the oral drug by bringing down the PASI score. Looking for an edge in the SMA race, which so far has been dominated by Biogen’s Spinraza and Novartis’ Zolgensma , Roche released fresh two-year data for its drug, Evrysdi . In the study, all patients had been previously treated with other approved or investigational SMA-targeting therapies, such as Spinraza and Zolgensma — and Evrysdi still improved or maintained motor function and showed an increase in levels of survival motor neuron protein. STARTUPS Michael Ehlers’ latest startup out of ATP is inspired by none other than sea squirts — specifically, the way they edit their RNA to metamorphose from tadpoles into their tube-like, immobile adult forms. Ascidian Therapeutics , which got former Dyne CEO Romesh Subramanian at the helm, is launching with $50 million . Back when Jack O’Meara and Quin Wills were initially setting up Ochre Bio , they jumped from their home base in the UK to the US to tap into a global network of investors. And the strategy is working fine, paving the path to a $30 million launch round to fund their development of new RNA therapies for liver diseases. Phoenicis Therapeutics is a relatively unknown clinical-stage biotech — or amalgamation of at least five biotechs. Nonetheless, it managed to raise close to $20 million to develop drugs for rare skin conditions, and appears to already have a pricing range in mind for its potential treatment of “butterfly skin” disease. Andre Turenne is now armed with $70 million to run his next act after Voyager , as the Atlas -backed biotech — which changed its name from EoCys — emerged from stealth mode with the goal to make covalent drugs for a range of autoimmune and inflammatory diseases. Turenne calls this a “complete open space.” Sanofi Ventures led the round. Four years into a journey to take a hydrophilic drug-linker platform for antibody-drug conjugates out of a French university and turn it into a viable business, Mablink Bioscience got the attention of Sofinnova Partners and Mérieux Equity Partners , who are co-leading a €31 million Series A . The tech essentially cloaks the cytotoxic molecules to make them undercover agents, FINANCING Neumora — formerly known as the Really Big Neuroscience Company that Bob Nelsen was putting together at ARCH — just closed a really-not-as-big Series B at $112 million . As it attempts to straddle the very fine line between hype and surreptitiousness, the hope is that the new round will take the startup through its lead program’s pivotal readout. If there’s one thing Gary Glick excels at, it’s raising money for his startups. Even in this soured financial environment. No sooner had he closed his whopping big launch round for Odyssey Therapeutics than he was off and running on the Series B . And as he brings the haul to $386 million, the CEO is ready to start inking deals. VectivBio now has $125 million more to work with. Luca Santarelli’s crew reported the raise just 20 minutes after it dropped early data from a small, open-label study on its lead candidate, apraglutide, a GLP2 agonist for short bowel syndrome with intestinal failure, a rare condition in which the body can’t absorb enough nutrients because the intestines are too short. Harvard spinout i2o Therapeutics raised $26 million in a private stock offering. The company specializes in improving the oral delivery of various compounds, such as nanobody-based drugs or macromolecules, which has led to partnerships with Sanofi and J&J . In particular, it’s spotlighted type 2 diabetes, obesity and inflammatory bowel disease. A host of other biotechs have looked to refill their coffers on the heels of an optimistic data readout. San Francisco’s DICE Therapeutics is no exception. The biotech announced a $250 million public offering just a matter of hours after it reported positive Phase I data in hopes of securing the money to fully develop its IL-17 franchise. In the same breath that scPharmaceuticals announced the FDA approved its drug-device to treat fluid overload in patients with specific types of heart failure, the biotech also kicked off a $100 million raise to push the product to the market. Its product, Furoscix , consists of a wearable device that delivers a subcutaneous formulation of the diuretic furosemide. CORONAVIRUS Directly addressing what one member of the European Parliament called “SMS-gate,” a Pfizer executive denied that the company’s vaccine deal with the bloc could have been negotiated via text message . The news comes months after the European Ombudsman condemned the Commission’s handling of requests for text messages between president Ursula von der Leyen and Pfizer CEO Albert Bourla , which reportedly led to a $1.8 billion deal for vaccine doses. Oxford and AstraZeneca’s nasal spray vaccine performed poorly in an early-stage study, squashing hopes for a quick advancement of the duo’s widely used Covid-19 shot via an alternative inoculation at SARS-CoV-2’s entryway. The Phase I study included 30 patients who hadn’t previously received a Covid-19 jab and 12 patients who took it as a booster. Bivalent booster shots specific to currently circulating Omicron strains will soon be available to children as young as 5 years old, after the FDA authorized Pfizer and BioNTech’s booster in children ages 5 through 11, as well as Moderna’s formulation in kids 6 through 17 years old. Both shots are specific to the Omicron BA.4/BA.5 subvariants. PEOPLE AstraZeneca and GSK settled their latest talent feud in court , clearing the way for 18-plus-year AstraZeneca veteran Chris Sheldon to start a new gig at the rival pharma next month. The resolution comes more than a month after AstraZeneca was granted an injunction to stop him from starting at GSK as the next senior VP of its commercial portfolio. As staff reductions romp across the industry, the RNA R&D and manufacturing company GreenLight Biosciences is the latest to bring out the axe. The company is reducing staff by 25% as part of a wider realignment where it will integrate its “platform team” into respective teams for plant and human health, as well as shift the focus from early- to later-stage projects. A month after laying off 20% of its employees, Palisade Bio’s CEO is also out the door. Thomas Hallam hit the exit and finance chief JD Finley took over as interim CEO. The penny stock, gastrointestinal-focused biotech disclosed the departure without offering any details on why Hallam’s nine-year tenure concluded, or where the outgoing CEO might be headed. As part of plans to shutter a manufacturing facility in the Long Island town of Hauppauge, NY, generic drug company Amneal Pharmaceuticals says it will lay off 13 employees there by the end of the year. The oral solids site had 89 employees prior to the layoffs, and the remaining 76 employees are expected to work at the facility until March of next year. The company said employees were offered the option of transferring to another site on Long Island. PHARMA The biopharma industry reputation is sliding again — and alarmingly fast. The pharmaceuticals, biotechnology and life sciences category fell almost 3 points (2.9) between the first and second quarter of 2022, according to corporate reputation monitor RepTrak, who says the drop is more significant than it seems as many people experience “pharma burnout.” After taking its Gilenya patent battle all the way to the Supreme Court last month, Novartis suffered yet another loss. The court denied its request to stay a lower court’s mandate invalidating a key patent for the MS drug, which would stall the introduction of a generic. But it isn’t done fighting yet. It’s not just temperature changes and turbulent weather: AstraZeneca wants to emphasize the effect climate change has on human health and spur more conversations with a corporate campaign now rolling out around sustainability and science. At the heart of the new “Science Can” effort is a two-minute short film that lays out the connection between climate change and public health . Pharma companies and even Congress have made efforts over the last year to ensure clinical trials are more representative of the patients they serve — but two researchers argue that isn’t enough . Writing in NEJM, Brigham and Women’s urologist Thomas Hwang and John’s Hopkins oncology professor Otis Brawley opined that achieving diversity in clinical trials will take a combination of federal incentives and regulations. Following in the footsteps of GSK and J&J , Viatris is reportedly considering a deal for its European consumer health programs that could reap more than $2.9 billion. Ever since it was formed back in 2020 from the merger of Mylan and Pfizer’s Upjohn unit, the generics maker has been looking to restructure, CEO Michael Goettler has previously made clear that he’s on a mission to trim back the company’s “non-core assets.” A new trend report from Amgen estimates that biosimilars resulted in $3.2 billion in savings last quarter alone. And though the last two years saw a decline in overall approvals, the number of programs in development — and the uptake of available biosimilars — is on the rise . At this count, of 39 approved biosimilars, only 22 have launched. As generic rivals cut into sales of Teva Pharmaceuticals’ blockbuster multiple sclerosis drug Copaxone in North America, the company has been accused of breaching antitrust rules in an attempt to delay competition across the pond. Specifically, the European Commission suspects that Teva misused the patent system and spread misleading information about a rival. The FDA signed off on a label expansion for GSK’s Tdap vaccine, Boostrix , to cover expectant mothers in the third trimester of pregnancy to prevent whooping cough (pertussis) in infants two months old and younger. They are too young for the pertussis vaccine already indicated for children, but the hope is that mothers can pass down protective antibodies. MARKETINGRX Move over Facebook: Pharma marketers are getting hip to TikTok. Amgen and AstraZeneca are two of the newest — with branded work for co-marketed severe asthma med Tezspire — joining the influx of pharma companies piloting marketing efforts on the social video channel. Amgen and AZ debuted their effort by adopting popular TikTok trends to better connect with users. And it’s not just about connecting to patients. Experts told Endpoints’ Beth Bulik that TikTok is unique among social platforms in the speed at which it can return feedback to marketers. With a worrisome flu season on the horizon, the CDC, Ad Council and American Medical Association are dusting off some influenza ads to promote vaccinations this fall. The trio is partnering again for the “Get My Flu Shot” public service campaign, now in its third year, with specific emphasis on reaching Black and Hispanic communities. Breaking new ground in clinical trial recruitment ads, Biohaven is looking for people living with obsessive-compulsive disorder using TV, radio and digital ads where, instead of calling on people to call a number or visit a website, stars real OCD patients sharing their thoughts, worries and hope. Acadia Pharmaceuticals is creating a crowdsourced mosaic of Rett syndrome photographs — inside the digital artwork of a young woman who is living with the condition. The “Rett Revealed” campaign showcases Emily Shifflet , a 27-year-old artist in Pennsylvania, and her “Confetti” painting that she created using eye movements and specialty digital software. For the rest of October, people in the Rett community can submit their own images to help “color in” the grayscale artwork and further bring Shifflet’s work to life with photos. Former NFL standout and now Fox Sports commentator Shannon Sharpe is no stranger to Sunday afternoon football banter. However, a recent appearance with the game day crew concerned a different topic — prostate cancer. Sharpe revealed for the first time that he had been diagnosed and treated six years ago, and launched his spokesman partnership with Johnson & Johnson’s Janssen Oncology to raise prostate cancer awareness among Black men. Just over a year ago, as Synthetic Biologics struggled to find cash for its C. difficile candidate, the team decided it was time for a reinvention . It’s since snapped up an oncolytic virus player and shifted the focus to cancer — and in the final stage of transformation, it changed its name to Theriva Biologics , complete with a new logo, to reflect the new vision. The nation’s largest lab provider is coming to your living room — with both its tests and a first-ever consumer advertising campaign. Quest Diagnostics is pitching its lineup of 50+ tests , from sexually transmitted disease screenings to allergy and metabolic panels, by emphasizing how it lets people skip the line at doctors’ offices and get results at home. Here’s a sampling of what you will find in this week’s MarketingRx roundup : On World Mental Health Day, pharmas, ad agencies and publishing partners launched a variety of efforts aimed at raising awareness and promoting workplace wellness; Horizon , Vertex were among Newsweek’s leading 2022 most loved workplaces; Insmed initiated an annual global day of good during which its employees volunteered service hours to benefit local communities; there are also a number of Marketing Moves you may want to keep track of. FDA+ Supernus found itself in the crosshairs of the FDA once again as regulators rejected its pitch for a Parkinson’s disease treatment. The rejection is not the first time this program, dubbed SPN-830 , has faced scrutiny: Supernus previously received an RTF for it back in November 2020. It’s touted as a less invasive alternative for patients suffering from “motor fluctuations.” It’s not often that the FDA publicly explains the rationale behind its rejections, but the agency is making an exception for Vanda . Striking back against the litigious biotech, CDER spelled out exactly why it refused the sNDA for Hetlioz ( tasimelteon ) in jet lag disorder, citing “inadequate justification” for its efficacy . Travere Therapeutics , formerly known as Retrophin and founded in 2011 by Martin Shkreli , disclosed that it expects the FDA to push out the PDUFA date for its lead candidate, sparsentan in IgA neuropathy, another three months to February. The agency unexpectedly requested that the biotech update its REMS to include liver monitoring, consistent with other drugs in the same class. The EMA’s CHMP just doled out positive opinions to a batch of 10 drugs, including two with higher profiles. Among the seven brand-name drugs it recommended for approval were tabelecleucel , the allogeneic T cell therapy branded as Ebvello made by Atara Biotherapeutics , and Takeda’s dengue vaccine. Making sure a pharma sponsor and the FDA are on the same page when it comes to a new drug development program, particularly around manufacturing, can be crucial to ensuring the drug gets a fair shake as the review process plays out. One aspect of this dialogue is the agency may issue an information request, and it’s now commissioning a contractor to assess how well the industry and regulators are adhering to a standardized process. Back in 2014, the FDA made very clear to the growing but under-regulated pharma compounding world that it would begin compiling a relevant list of bulk drug substances that they may use. But the process proved slow and painful. Fast forward eight years later, the trade association for drug compounders reached a settlement with the FDA that will spur the agency to more promptly review these long-pending nominations for active ingredients. MANUFACTURING One of Eli Lilly’s manufacturing sites has been in the crosshairs of the FDA and the Department of Justice for some time now, and an inspection report from this summer is not painting a positive picture. Reuters reported that a July inspection revealed several issues surrounding quality control at a Lilly site in Branchburg, NJ, that manufactures some major products. Shortages for the Adderall have now hit a total of seven manufacturers for both extended and immediate-release capsules, according to the American Society of Health-System Pharmacists. Among those who have reported shortages are Rhodes , Sandoz , Teva , Amneal Pharmaceuticals , Camber Pharmaceuticals , Par Pharmaceuticals and Sun Pharma . After seeing $10 billion in market value disappear into thin air, WuXi Biologics has cause to celebrate as it finds itself removed from the US Department of Commerce’s unverified list. The China-based contract research and manufacturing giant was initially placed on the list in February of this year after delays in verifications for certain products that were being exported to the US. As Ionis continues to net major deals and collaborations with large pharma companies, the RNA player is looking to expand its manufacturing capacity. Ionis will have a chemistry and manufacturing site built in the city of Oceanside, CA, north of San Diego, that will be double the size of its current facility . Last year, Roche and Genentech paid $50 million for licensing rights to Lineage Cell Therapeutics’ OpRegen program, a cell therapy that looks to regenerate healthy versions of retinal pigment epithelial cells in patients’ eyes. Now the biotech is growing its physical presence with a new R&D facility in the US — which it says can accommodate more partnered projects — and a manufacturing expansion in Israel. Having grown its footprint across the globe this year, Cytiva is boosting its cell therapy manufacturing capabilities by acquiring CEVEC Pharmaceuticals , a Cologne, Germany-based company centered on cell line development and tech for the manufacturing of viral vectors. The two companies have been working together for several years. Maiden Pharmaceuticals , an India-based producer of generic drugs, came under fire after several of its cough syrup products were linked to the deaths of more than 60 children in Gambia. According to the WHO, lab samples contain poisonous contaminants such as diethylene glycol and ethylene glycol — chemicals mainly used in antifreeze or brake fluid. In this week’s Manufacturing roundup , Endpoints’ Tyler Patchen recaps news like how manufacturing giant Lonza can add more FDA-approved therapies to its repertoire as Zynteglo and Skysona , two bluebird gene therapies manufactured at its Houston site, scored OKs this quarter; Eisai opened a $68 million-plus injection and research building in its industrial park in Japan; Germany’s Evonik netted a “long-term supply agreement” with Phathom Pharmaceuticals to develop and eventually commercialize drugs to counter gastric acid-related diseases; and more. DON’T MISS Groceries, home goods, auto care and … clinical trial recruitment? Walmart joined the wave of health and retail conglomerates jumping in on pharmaceutical research, unveiling the new Walmart Healthcare Research Institute . While the retail chain won’t be running actual trials, its initial focus will be on identifying patients who may benefit from studies in chronic conditions and building trust with them. The equity aspect is also a resounding theme. Fresh off a $78 million donation and a spring merger that brought with it a new logo, Seattle’s Fred Hutchinson Cancer Center will receive $710.5 million over the next decade from Jeff Bezos’ parents, Jackie and Mike Bezos . Funds will bankroll infectious disease and cancer research, with the biggest pool, at $300 million, going toward recruiting 36 new researchers. Triplet Therapeutics , an Atlas -founded biotech focused on Huntington’s disease, is no longer operational , chief exec Nessan Bermingham wrote in a short LinkedIn post. In December 2019, Triplet debuted with a $59 million Series A. The news was first reported by STAT, which noted that recent failures of other antisense drugs for Huntington’s gave investors cold feet. With the midterm elections approaching next month and Republicans likely to win back some control, Republican Sens. James Lankford (OK) and Mike Lee (UT) recently introduced a bill that would roll back the Democrats’ recent drug pricing victory. Days later, President Joe Biden doubled down by signing an executive order directing HHS to consider what more it can do to drive down prescription drug costs.