Avadel CNS Pharmaceuticals LLC

Dive Brief:The Federal Trade Commission will use its full legal authority against drugmakers that impede competition by improperly listing patents in a government database that controls how generic manufacturers can enter the market, under a policy statement the commission approved Thursday.According to FTC Chair Lina Khan, pharma companies can weaponize the database, called the Food and Drug Administration Orange Book, because any generic maker that applies for approval of a drug with a listed Orange Book patent can be sued by the branded manufacturer and blocked from entry for 30 months.The policy statement highlights the antitrust regulators tightening scrutiny of drugmakers marketing, patent and acquisition practices. The FTC recently slowed Amgens $27.8 billion acquisition of Horizon Therapeutics until Amgen agreed to safeguards against the bundling of drugs in the combined company. The agency is also carefully reviewing Pfizers planned $43 billion takeout of Seagen.Dive Insight:The federal law known as the Hatch-WaxmanAct set out specific legal steps for the orderly entry of generic drugs once patents and other forms of legal exclusivity expire. Among the requirements is that branded manufacturers must submit to the FDA all patents covering an approved product, including those issued after approval, for publication in the Orange Book.Any manufacturer that applies for approval of a generic version of a marketed drug must certify that they wont violate a listed Orange Book patent, or that a listed Orange Book patent is invalid or wont be infringed. In the latter instance, the branded manufacturer can sue and win a 30-month stay on approval of the generic companys application.The FTC is arguing that many listed patents dont fit the legal guidelines under Hatch-Waxman and subsequent refinements. Khan cited a court case decided earlier this year in which Jazz Pharmaceuticals lost a bid to block Avadel CNS Pharmaceuticals from launching a competitor to the narcolepsy drug Xyrem by using Orange Book-listed patents on its risk evaluation and mitigation strategies program.Abuse of patent rights can really deprive Americans have access to more affordable drugs and medical products, and the FTC has a long history of challenging these practices when they violate the antitrust laws, Khan said at an open FTC meeting in which the policy statement was endorsed in a 3-0 vote.The policy statement were considering today builds on that important work and explains that patents that are improperly listed in the Orange Book can maybe an unfair methods of competition and violate the FTC act, she said.FDA Commissioner Robert Califf expressed support for the policy statement, saying his agency stands ready to assist the FTC in identifying and addressing the practices cited by the commission.Industry groups Pharmaceutical Research and Manufacturers of America and Biotechnology Innovation Organization did not respond to requests for comment on the policy statement.In a note to clients, TD Cowen analyst Rick Weissenstein wrote he is skeptical the FTCs actions will result in much action. It is not clear there is a real problem with the Orange Book, but this fulfills the White House pledge to implement patent reforms, he wrote. '

The US Court of Appeals for the Federal Circuit is upholding an injunction that states that a patent related to Jazz Pharmaceuticals’ narcolepsy drug should be delisted from the FDA’s generic drug compendium known as the Orange Book. The patent in question, called the ‘963 patent, is related to Jazz’s “single-pharmacy distribution system” which is designed to control access to drugs prescribed to narcolepsy patients, which can be abused. The patents include a central pharmacy and computer database that can track prescriptions and patients. Avadel CNS Pharmaceuticals originally sought to delist the patent in question, as it related to the system under its REMS. And after listing the patent in the Orange Book, Jazz filed a patent infringement lawsuit against Avadel, dropping a 30-month stay that blocked the final FDA approval of Avadel’s narcolepsy drug. However, in November, the judge in the Delaware case ruled that the FDA should delete the patent from the Orange Book, claiming that the ‘963 patent’s claims were “directed to systems, not methods.” But, in the appeal, Jazz stated that the district court had “abused” its discretion in finding that “the ’963 patent is not a method-of-use patent for listing and delisting purposes under the FDCA,” the appeals court case stated. Jazz also stated that even if the patent was not a method-of-use patent, the court still had abused its “discretion” in determining the delisting. However, the appeals court’s decision noted: Jazz further contended that in 2014, the regulatory environment allowed Jazz to list the patent which fell into a category of patents that were neither required nor forbidden to be listed. And because it listed the patent, that does not provide Avadel with the power to request an order for delisting. However, the court disagrees and finds that the Delaware court’s decision is correct. “As the ’963 patent claims neither and has been asserted in a patent infringement action against Avadel, provides Avadel with a delisting remedy. The district court therefore correctly ordered Jazz to seek delisting of the ’963 patent from the Orange Book,” the court decision said. The decision from the appeals court further stated that it found Jazz’s remaining arguments “unpersuasive” and is asking the FDA to delist the ‘963 patent. In an email to Endpoints News, a Jazz Pharmaceuticals spokesperson said:

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 . Drew Armstrong has officially joined the Endpoints team. We are thrilled to welcome him and excited for his new vision. If you have any feedback or thoughts, don’t hesitate to reach out. You can reply to this email to reach an editor. Biogen, Seagen lock in CEOs Two high-profile biotech CEO searches coincidentally culminated in appointments on the same day. Chris Viehbacher , the former CEO of Sanofi , will become Biogen’s next leader. He steps into Michel Vounatsos’ shoes at a tumultuous moment sandwiched between a controversial Alzheimer’s drug launch and a promising one. Seagen , meanwhile, tapped David Epstein of Novartis fame to steer the ship in the wake of Clay Siegall’s sudden resignation. 2022 so far — by the numbers This year, with Nasdaq iced over, everything is falling behind. We asked DealForma chief Chris Dokomajilar to do a special 10-month run of the numbers to give us a clearer picture of where we’re headed in a stressful 2022, and you can see the cracks widening in almost every key spot. It is important to note, though, that with the inevitable end of the pandemic boom, we’re still seeing historically high rates of investing. But silver linings are few and far between. Pharma on Twitter As Elon Musk’s takeover of Twitter — and almost-daily controversies — causes confusion and consternation, Eli Lilly got swept up in the chaos . Amid an overhaul of the site’s verification system, the pharma giant became a target for impersonation, with a fake Lilly Twitter account posting a message pretending the company had made insulin completely free. Meanwhile, other pharma advertisers on the platform are also trying to figure out what to do . Flagship stems the breach Eighteen months after Repertoire Immune Medicines unveiled a whopping $189 million raise, the company confirmed that it has laid off 65 staffers , or close to half the employee roster. Flagship Pioneering, which founded the startup, is sending in one of its senior partners to pick up the pieces. And Torben Straight Nissen , who took the president’s job at struggling Rubius , has some experience with setbacks. Repertoire hasn’t mentioned what has gone wrong, just that it plans to devote itself to its platform for immune medicines. PREMIUM Phase III bound Serial biotech entrepreneur Lonnie Moulder has scored some big wins along the way, most notably the $9 billion he racked up selling MGI and Tesaro . And now the new startup he’s helping manage as executive chair is making a bold move into Phase III — damn the market turmoil that has largely iced IPOs. Zenas BioPharma , based in Waltham, MA with staffers primarily in the US with some clinical ops in China, put together a $118 million round to fund the trial for obexelimab , a drug it got from Xencor last fall with a mix of equity and milestones. Chat with Altos Labs A few weeks ago, Endpoints founder and editor John Carroll had a chance to sit down with Rick Klausner and Hal Barron to discuss in some depth about their startup Altos Labs , which is using some very deep-pocket backing to establish an institute of their own to go after cell rejuvenation. You can now read the transcript to hear their thoughts directly . Fungi mining draws backing SoftBank -backed Hexagon Bio , which is mining fungi to find new drugs for cancer and infectious diseases, is raising another round of financing, Endpoints News learned. It has so far raised $67 million in a new round, but the total offering could eventually go beyond that figure, to almost $80 million . PEOPLE Depressed by the market, another handful of biotechs brought down the axe . Sumitomo Pharma is laying off 360 employees at its Sunovion unit; Nabriva is chopping about 40% of its workforce to focus on a treatment for its acute bacterial skin and skin structure infections; and vaccine manufacturer Valneva is shrinking its headcount by 20% to 25% in the wake of a setback on its Covid-19 shot that forced it to resize. Adaptimmune has a bitter pill to swallow after GSK axed its partnership in late October, coming in the form of a reorganization and budget cuts. Citing a need to prioritize certain high-value programs during challenging economic times, the TCR biotech says it will let go of 25% to 30% of employees as it limits resources for non-core programs. Clovis Oncology’s rocky 13-year run from startup developer to commercialization — while surviving accusations of playing fast and loose with the data — may be coming to a close. The biotech disclosed that it is on course to run out of cash in a matter of weeks and may have no alternative but to file for bankruptcy . As cash dwindled, it laid off 115 staffers. Now that it’s gotten both clinical holds lifted for the blood cancer drug emavusertib , Curis is ready to move full speed ahead. But first, it’s going to prune the pipeline — with a wave of layoffs to follow. As a result of reallocating resources and deprioritizing other programs, the biotech is shrinking the workforce by 30% . R&D Two years after an accelerated approval, GSK’s BCMA-targeting antibody-drug conjugate flunked a confirmatory Phase III study in multiple myeloma, raising doubts about the pharma giant’s plan to move it up to earlier lines of treatment in a crowded space. Pitted head-to-head trial against a standard of care combo dubbed PomDex , Blenrep failed the primary endpoint of progression-free survival. Amgen may be way late to the obesity game, but judging from the analysts’ response to its snapshot of early-stage data, the market scouts are still loving the blockbuster potential of AMG 133 . An update at AHA for its anti-GIPR/GLP-1 peptide conjugate enjoyed warm reception and comments that it looks “solidly competitive,” setting the stage for full data in a few weeks. Norbert Bischofberger went back to his old colleagues at Gilead to pluck an AML drug off its back shelves and put it into the late-stage pipeline at Kronos . But after working out a shorter Phase III path for the SYK inhibitor using a unique primary endpoint, he’s pulling the plug on the trial , beleaguered by a host of issues relating to enrollment. At the annual Liver Meeting, GSK unveiled results from a Phase II trial on its hepatitis B treatment, which it said earlier this year could “lead to a functional cure” for the liver infection. While not quite hitting a home run, the program lead described the drug as hitting first base — paving the way for future combinations. During his Q3 earnings call, Amgen CEO Bob Bradway touted a cardio program called olpasiran as one of the top drugs in the pipeline. Days later, the pharma giant took the wraps off a detailed and updated outline of Phase II data as it explained its hopes for a siRNA drug designed to wipe out lipoprotein(a) levels in patients suffering from atherosclerotic cardiovascular disease. CG Oncology has been quietly chugging along — only giving updates at sequential cancer conferences ahead of a full readout on its oncolytic virus cancer therapy next year. In its latest at SITC, the Irvine, CA-based biotech showed up with longer-term data on its therapy, CG0070 , in combination with Merck’s Keytruda . Hovering around penny stock territory, New Jersey-based Cyclacel Pharmaceuticals is finally going to call it quits on a Daiichi Sankyo -partnered cancer drug candidate that saw a Phase III flop in acute myeloid leukemia in late 2014. J&J and Idorsia presented new Phase III data for their hypertension drug, aprocitentan , breaking down how it reduced blood pressure by a statistically significant margin and maintained its effect for up to 48 weeks. Researchers were testing it in patients whose high blood pressure is tough to control and in combination with standard background therapies. As Roche prepares to take a kidney disease drug into Phase III, Ionis revealed new details on a Phase II trial that pushed the pharma giant to acquire the full rights. IONIS-FB-LRx , an antisense compound, hit its primary endpoint in immunoglobulin A nephropathy. With the new data, Ionis spelled out reduction in urine protein excretion as well as kidney function. Q3 EARNINGS Just over a year ago, the FDA slapped AstraZeneca with a clinical hold on its MCL-1 inhibitor to look into safety information, putting the Phase I trial in limbo. The drug became one of three new molecular entities to be swept out of the early-stage pipeline as part of AstraZeneca’s Q3 housecleaning . The other two are a Moderna -partnered mRNA therapy for solid tumors and an antibody aimed at chronic kidney disease. EQRx placed a substantial bet it could shake up the US healthcare system, promising to bring a swath of fast-follow drugs priced substantially lower. But the business model appears to be unraveling as it decided its first effort — a PD-L1 inhibitor licensed from China’s CStone — is no longer commercially viable in the US . It also now plans to pursue “market-based pricing” for the two other clinical candidates. As biotechs around the sector reported their third quarter earnings this week, Xilio Therapeutics , Protagonist Therapeutics and Evaxion Biotech slimmed down their pipelines and revealed program cuts, continuing the trend seen all year throughout the sector as companies felt the weight of the bear market. While the impact of inflation, already some of the highest in decades, was not quite apparent in Bayer’s operations this year, execs told investors and analysts that they “expect the full cost inflation effects across the value chain to actually materialize” in 2023. They also offered an update on plans for Eylea , the top-selling Regeneron -partnered eye drug. After getting off to a rather rocky start in July, GSK’s consumer health spinoff Haleon is upping its full-year sales guidance on the heels of what CEO Brian McNamara called a “strong quarter of growth.” The company attributes the growth to the roughly 12% uptick in oral health sales and solid respiratory figures as we enter cold and flu — and likely Covid — season. LAW The US Supreme Court agreed to take up a long-running patent battle between PCSK9 frontrunners Amgen and Sanofi that has spilled into a broader issue of how narrowly pharma patents should be written. Amgen filed the initial petition last November, claiming that a prior court ruling puts an impossible expectation on companies filing patents. Sanofi, on the other hand, argued that Amgen’s patents were overly broad. On the other hand, SCOTUS declined to hear Bristol Myers Squibb’s petition to revive a $1.2 billion verdict against Gilead , the latest setback in a years-long legal tussle that began with their respective subsidiaries, Juno and Kite . Bristol Myers had argued that an appeals court’s invalidation of its CAR-T patent “may threaten innovation.” It’s been 16 years since AstraZeneca’s blockbuster asthma inhaler Symbicort came to market in the US, hauling in more than $13 billion over just the last five years and becoming the market leader in the class. Viatri , which earned approval earlier this year for the first generic, just won a court case related to an AstraZeneca patent on Symbicort, but that’s not the end of the road for Symbicort litigation. The FTC is calling to keep strict statutory limits on Orange Book patent listings, explaining in an amicus brief that patents related to REMS distribution systems should not block generic or other competition. In particular, it singled out Jazz Pharma for abusing the process, in response to Avadel CNS Pharmaceuticals’ motion to delist one of Jazz’s patents relating to REMS. A charity backed by a coalition of cancer drug manufacturers wants to provide financial assistance to Medicare Part D patients dealing with expensive cancer drugs. But HHS insists that any monetary help would be a violation of anti-kickback laws. To fight that decision, the nonprofit charity filed suit in Virginia district court , saying the HHS was arbitrary and capricious in this decision. Just one month after the news that Teva and Eli Lilly were going to duke it out in federal court for patent infringement, a jury in Massachusetts ruled that Eli Lilly has to pay Teva a combined $176.5 million on three types of damages. Teva, which markets the migraine treatment Ajovy , sued Lilly over its rival drug, Emgality . CORONAVIRUS The EMA offered a positive recommendation for the first protein-based adjuvanted Covid-19 booster in Europe, developed by Sanofi and GSK . The BARDA-funded vaccine, known as VidPrevtyn Beta , contains a version of the spike protein found on the surface of the Beta variant of the coronavirus, and an adjuvant to strengthen the immune response. While acknowledging that Veru’s potential drug for Covid-19 hospitalizations hit the mark on mortality in a small trial, and may have enough for an EUA with a confirmatory trial add-on, the FDA’s briefing documents ahead of an adcomm also pointed to uncertainties in the data. But the panel voted narrowly against the repurposed cancer drug, arguing the benefits do not outweigh the risks. Agenus’ invariant natural killer T cell-focused spinout MiNK Therapeutics arrived at SITC with some early cancer data, but it also dropped positive results of a Phase I/II study of its lead candidate, made from those same rare immune cells, treating acute respiratory distress syndrome, a serious complication of Covid. Seeing that the drug boosted patients’ chance of survival, MiNK says it will push forward the program pending a contract with DARPA. Novavax is tempering its expectations once again on Covid-19 vaccine sales, as it reported $725 million in Q3 and around 94 million doses administered so far. Despite falling demand for booster shots, though, it is forging ahead with its booster candidate to counter the Omicron variant and touting topline results from a Phase III trial. CELL/GENE TX Just when you thought BioMarin has completed the package on hemophilia A gene therapy valoctocogene roxaparvovec ( valrox ), execs put out word that the FDA has upped the ante one more time and hinted that it may extend the review to look at three-year-data — putting a damper on any lingering hopes for a Q1 approval by the PDUFA date next year. Immunotherapy and oncology player Fate Therapeutics put out word that collaborator ONO Pharmaceutical is exercising its option for a preclinical HER2-targeting, off-the-shelf CAR-T cell therapy called FT825 / ONO-8250 . The pair will now jointly develop and commercialize the drug for the US and Europe, while ONO grabs exclusive rights for the rest of the world. Verve Therapeutics is running up against a regulatory wall as it looks to expand the clinical trial of its base editing therapy to the US. The FDA placed the program , which is designed to permanently turn off the PCSK9 gene in patients with dangerously high cholesterol levels, on clinical hold. Three patients have been dosed in New Zealand and the UK since July. With all hands on deck to enroll the first patient for its lead sickle cell trial, Beam Therapeutics will pull back clinical plans for a second base editing therapy aimed at sickle cell disease. While it had hoped to file an IND in 2022 for BEAM-102 , which takes an alternative approach than BEAM-101 , the biotech said it needs to focus while also researching new technologies to go with the drug. DEALS A few days after Amgen charted a Phase III map for an up-and-coming cardio drug, the biotech behind its development decided to cash out. Arrowhead Pharmaceuticals sold its royalty stake in olpasiran , a siRNA drug developed using its RNAi tech, to Royalty Pharma for $250 million in upfront cash, plus another $160 million in milestones. As it moves to position itself beyond pandemic stardom, Moderna is spidering out into a number of biotech spheres. In its latest move, Moderna is adding another antibody discovery collaboration — this time with Harbour BioMed through its new subsidiary Nona Biosciences . Harbour sports a platform that specifically develops heavy chain-only antibodies. It will pay a small upfront of $6 million to explore packaging those antibodies in mRNA systems. Little Nordic Nanovector announced the end of its journey in a reverse merger , roughly three months after announcing it would essentially sell itself for parts. It will be swallowed by another biotech based out of Norway, APIM Therapeutics , which will unveil a new name at a later date. Moving forward, it will be working on approaches to boost responses to other common cancer immunotherapies. In the wake of a report to sell off its European consumer health business, Viatris is continuing its plot to shift strategies with two acquisitions that beef up its ophthalmology portfolio. It will buy Oyster Point Pharma and Famy Life Sciences in deals valued between $700 and $750 million . The company says the two new subsidiaries could potentially add more than $1 billion in sales by 2028 — a figure that was viewed skeptically by analysts on the call. Sanofi dished out $21.5 million upfront to partner with Insilico , marking the Big Pharma’s third major AI drug deal this year. The pact covers up to six undisclosed targets, with downstream milestones potentially adding up to $1.2 billion. The French pharma giant noted that the tie-up will boost discovery efforts out of its R&D center in China. STARTUPS Lipidio Pharmaceuticals launched right before Covid-19 took the world by storm, initially focusing on metabolic indications. More than 2.5 years later, the biotech has added dermatology to that list and secured some of the industry’s most well-known investors — think John Maraganore and Brett Saunders — for a Series A extension round . For patients with diabetic retinopathy, anti-VEGF injections to the eye are often the only non-surgical option to stave off vision loss. But a Novo -backed startup is joining the search for drugs that can be given orally. Breye Therapeutics’ $4 million seed funding should push its lead drug, one from Zealand Pharma’s shelves, into clinical testing. With founders out of Mass General and Harvard, Sensorium Therapeutics wanted to take the next step in the mental health and CNS space with what it calls psychoactive drugs. And investors are now pouring $30 million in Series A cash into its approach of mining plants and fungi for potential treatments of anxiety and depression. Can targeting a mitochondrial pathway previously thought to be undruggable crack the code in devastating neurodegenerative diseases, such as Parkinson’s and ALS? For NRG Therapeutics , that’s the £16 million question . Its research, according to the two GSK vets behind it, has pinpointed a way to protect mitochondria from the hallmark neuronal damage seen in neurodegeneration. Funds will be used to get NRG through IND-enabling studies. Two former Stanford researchers nabbed a $41 million launch round to learn the secrets of the “secretome.” Juvena Therapeutics intends to use the funds primarily to build out its map of secreted proteins and understand how they affect chronic conditions, while also advancing a handful of discovery-stage experimental drugs. FINANCING Tony Coles set out to build “the premier neuroscience company” at Cerevel . And that means putting fundraising plans in place well in advance. Just weeks after tying the knot on a $599 million haul — from a dual stock sale and convertible debt arrangement — the biotech filed a statement with the SEC to raise up to $900 million over the next few years. Kura Oncology is set for a few more years, thanks to some new partners . Bristol Myers is investing $25 million into the biotech as an equity investment, while Hercules Capital is coming on board with a term loan facility worth $125 million. If maxed out, the funding will extend Kura’s runway into 2026. Getting a fresh start after selling its CGRP portfolio to Pfizer , Biohaven reported in its Q3 earnings that it closed a public offering in late October to raise $301.9 million . The biotech didn’t necessarily need the cash — it had enough from the buyout — but some large funds wanted to invest, said CEO Vlad Coric . PHARMA AstraZeneca and Merck executives are now raising concerns about how President Biden’s new drug price negotiation law will impact cancer drug development moving forward as the clock for negotiations begins with the first approved indication. AstraZeneca’s Pascal Soriot went as far as to say that his company may no longer launch new cancer drugs in the US unless it’s for a large enough indication to keep that clock from starting too soon. At the request of the FDA, GSK will restrict the second-line maintenance indication for Zejula ( niraparib ) to only certain cancer patients with deleterious or suspected deleterious germline BRCA mutations (gBRCAmut). The decision is based on the FDA’s review of the final overall survival analysis of the Phase III trial that led to this approval in the first place. Regeneron’s Libtayo made it into the exclusive club of PD-(L) inhibitors approved, in combination with chemotherapy, as a frontline treatment for a broad swath of lung cancer patients. Based on Phase III overall survival data, the FDA granted Libtayo an OK in adult patients with advanced non-small cell lung cancer with no EGFR, ALK or ROS1 aberrations. Weeks after celebrating the first cancer win for its Imfinzi and Imjudo duo, AstraZeneca is once again breaking out the party hats. The PD-L1/CTLA-4 combo scored a label expansion in metastatic non-small cell lung cancer alongside platinum-based chemotherapy. Just last month, the drugs won a nod in the most common type of liver cancer. Seagen’s top-selling drug just scored another indication , a few weeks after execs boosted their full-year sales expectations. The company’s Takeda -partnered antibody-drug conjugate Adcetris is now available to pediatric patients 2 years and older with previously untreated high-risk classical Hodgkin’s lymphoma, in combination with a standard-of-care chemotherapy regimen. Following in the footsteps of the EU, the UK’s MHRA signed off on Sanofi and AstraZeneca’s RSV antibody nirsevimab . It will be the first single-dose option for all newborns and infants during their first RSV season. MARKETINGRX Looking to get an oncologist’s attention with a branded drug message? Keep it short and simple, but don’t forget the data. That’s some of the advice emerging from ZoomRx’s deep dive into oncology marketing messaging to healthcare professionals. Messages that contained 10-14 words were found to be the most effective. October may be over, but Merck is continuing to drive its awareness efforts around breast cancer — especially focused on the rare triple negative subtype and Black women who are disproportionately affected. Actress Yvonne Orji , who also holds a master’s degree in public health, narrates the three-video docuseries at the center of “Uncovering TNBC,” where she interviews three Black women about their experiences. More than half of people living with chronic obstructive pulmonary disease in the US are undiagnosed. It’s not a brand new problem, but it’s one AstraZeneca is shining a light on with marketing and awareness efforts during November’s National COPD Awareness Month. The pharma giant is engaging leading pulmonologist MeiLan Han , as a partner. For Reckitt , the focus for COPD awareness month is on the other use of its well-known over-the-counter cough and cold remedy Mucinex : thinning and loosening mucus in chronic bronchitis patients. Its first-ever effort aims at helping physicians identify people with undiagnosed chronic lung disease. Pharma and healthcare ads miss the mark on realistic portrayals of women, a new study from WPP finds. Asked how they’re being depicted in healthcare ads versus the way they actually see themselves, many women don’t see themselves in those ads — but they want to. The most glaring disconnects were around weight, reproductive care and mental health. Astellas is highlighting the people behind its oncology efforts with its latest corporate campaign. Shot in black-and-white, the “Changemakers” video series features some of the real Astellas Oncology employee scientists, researchers and business people talking about their passions and reasons for doing what they do. With the messages, Astellas is hoping to speak to physicians and healthcare providers. Independent advertising agency Klick Health announced its first-ever global expansion this summer — and now it has lined up its leadership , with managing directors in Latin America, Europe, the Middle East and Africa, plus an Asia Pacific leader to be announced soon. The new leaders will be tasked with building regional and local offices. J&J’s Janssen detailed progress in the first year of its peripheral artery disease campaign, “Save Legs. Change Lives,” aimed at reaching Black Americans; AstraZeneca is looking to remove clinical trial challenges with a “hybrid” tech platform; Eli Lilly is set to launch its first-ever connected suite of diabetes products this year, hooking together an app, insulin pen and a “smart button” data keeper — You can learn about all these and more in the MarketingRx roundup . FDA+ While Congress punted on adding new accelerated approval reforms to the user fee legislation, the FDA appears to be taking the matter into its own hands. ADC Therapeutics revealed, as part of its Q3 earnings report, that it’s taking a step back to reevaluate its experimental CD25-targeted antibody-drug conjugate after the FDA asked for a confirmatory trial to be “fully underway” prior to accelerated approval submission. BrainStorm Cell Therapeutics’ first attempt to approach the FDA with its ALS treatment has been slapped down with a refusal to file letter from regulators. The move comes after the FDA, in a rare public slapdown, said in March 2021 that Phase III data for its NurOwn therapy were “not at all statistically significant.” Building off President Joe Biden’s executive order from July 2021, the FDA and Patent and Trademark Office are looking to forge a tighter bond on everything from “skinny” generic drug labels to better training patent examiners. As part of building this closer relationship, the FDA and USPTO will hold a public listening session in January. AstraZeneca’s experimental asthma drug scored an overwhelming thumbs up from the FDA advisory committee for its use in adults. But when it came to adolescents and kids, the panel of external experts was less sure. The mixed votes could cast a shadow on the aspirations at AstraZeneca, which had proposed a broad label in its NDA filing for PT027. With the growth in biologics spending, interchangeable biosimilars that can be substituted without a doctor’s note will be key to increasing competition , a top FDA official said at a conference — where officials also discussed key flexibilities that they can make around the development of such copycat drugs. MANUFACTURING Towards the end of the summer, Pfizer was facing the heat from a labor action at a manufacturing facility in western Australia as workers walked off the job in protest of what was seen as “substandard pay.” Now, another similar labor action in Australia is turning up the heat even more , with over 100 workers downing tools and demanding a pay rise. As Novartis continues to reshape itself, the company is shuttering one of its gene therapy manufacturing sites in the US. The closure of a site in Libertyville, IL, a city to the northeast of Chicago, follows a “comprehensive manufacturing site network evaluation,” the company said. The decision will cause 275 jobs to be axed . Following a 10-day inspection earlier this year, the FDA sent a warning letter with several pointed questions to a Phoenix-based site, which is run by Abraxis Bioscience and owned by Bristol Myers Squibb . According to regulators, it did not effectively implement corrective actions and preventive actions or adequately control its aseptic processing line and manufacturing operations. In response to the FDA’s call on all drug manufacturers to improve the safety of the US drug supply and conduct risk assessments of products to detect potentially cancer-causing nitrosamine impurities, the generic drug industry is pushing the agency to take a more risk-based, scientific approach to the way it’s evaluating these impurities. The FDA has had its eye on the pharmaceutical manufacturer Lupin for a while, and an inspection of a facility tasked with developing biosimilars brought to light several quality control issues . The 10-page Form 483 had a total of 18 observations, starting with that the aseptic monitoring for a filling and closing machine was inadequate. The explosive growth in clinical cell therapy programs is driving Charles River Laboratories’ next expansion. The outsourcing player is planning to boost its cell therapy manufacturing capabilities in Memphis, TN, adding nine processing suites and bringing the total number of suites to 23. Global Healthcare Opportunities , otherwise known as GHO Capital , and The Vistra Group joined hands to acquire a controlling interest in the Alcami Corporation ; The CDMO Wheeler Bio kicked off construction on a manufacturing facility in Downtown Oklahoma City; DNA sequencing company Illumina launched a new solutions center in Dubai — check out what else you missed in the Manufacturing roundup . DON’T MISS In a groundbreaking first, researchers and doctors from the University of California San Francisco, Duke and the University of Ottawa treated a baby with Pompe disease, a debilitating genetic disease, while she was still in her mother’s uterus . The case, published in NEJM, is the first instance that an enzyme replacement therapy, a type of treatment used for Pompe and other lysosomal storage diseases, was given to an unborn child. Faze Medicines , which launched in 2020 with an $81 million Series A and a goal of developing a treatment for ALS and other neurodegenerative diseases through molecular condensates, shutting its doors , according to employee social media posts and a report in STAT. Third Rock , an investor, said “the science did not progress sufficiently to meet our bar for further investment.” Ipsen announced a positive late-stage readout on Onivyde , which helped patients with pancreatic cancer live longer in a Phase III trial. But the biggest winner could be Merrimack Pharmaceuticals , a biotech that shut down operations in 2019 after repeated failed attempts at getting another drug through the clinic.