Nanjing Noratech Pharmaceutical Co., Ltd.

Novartis has filed a lawsuit against the FDA after the agency approved a generic version of its top-selling product Entresto. Two weeks ago, Novartis CEO Vas Narasimhan referred to the initial wave of drug pricing effects tied to the Inflation Reduction Act (IRA) as “manageable.”What the company appears to be finding unmanageable, however, is potential near-term generic competition to its heart failure blockbuster Entresto.On Wednesday afternoon in federal court in Washington, D.C., the Swiss company filed a lawsuit against the FDA, claiming that the U.S. regulator’s approval of a generic version of Entresto is unlawful.The complaint comes a week after the FDA approved an Entresto generic from MSN Laboratories. The agency also rejected a Novartis-orchestrated Citizen Petition, which asked it to block the entry of generic versions of Entresto.The petition, which was submitted in September 2022, had asked the agency to deny the approval of any Entresto generic until Feb. 16 of this year. It also petitioned to prevent the FDA from approving any Entresto generics that would violate Novartis patents due to expire in 2033 and 2036. The FDA rejected the first request because it has already passed. The second and third requests were denied because the agency said that generics can avoid infringement simply by adjusting their labels.Novartis is seeking to preserve U.S. exclusivity for Entresto as long as possible. The company owns a series of patents on the drug, with some expiring in 2025, 2026 and 2027, according to FDA records.In 2026, government-negotiated prices Entresto will kick in. Those prices are set to be published Sept. 1 of this year. Entresto was approved by the FDA in 2015. The oral treatment is a combination of the neprilysin inhibitor sacubitril and the angiotensin II receptor blocker valsartan.In its complaint, Novartis alleges the FDA’s conduct is unlawful because it encourages labeling that “inappropriately rewrites Entresto’s approved indication.” Novartis also argues that MSN’s label for its generic “deletes critical safety information contained in the Entresto labeling.” Further, the company contends that the FDA, in denying Novartis’ petition, has “bound itself to approved generics that do not have identical active ingredients to Entresto.” This is another in Novartis’ attempts to derail generic competition for Entresto. In 2022, the company filed a lawsuit against generic drug makers Viatris, Alembic, Crystal and Nanjing Noratech, as well as MSN. In that complaint, the company claimed infringement against a patent due to expire in November 2026.That suit followed an infringement claim against generics maker Torrent Pharma, which was filed in December 2021.In addition to reaching confidential settlements with "several" generics filers, the company has had mixed success in other court cases against generic drug makers.Entresto is Novartis’ top-selling product, raking in revenue of $6 billion last year and $3.8 billion in the first half of this year.

▎药明康德内容团队报道7月14日，迈诺威医药宣布，该公司申办的去氧胆酸注射液在中国颏下脂肪堆积（俗称“双下巴”）人群的随机、双盲、平行、安慰剂对照的3期临床试验（MEI005-SMF-CN-III）成功达到所有主要及次要终点，展现出良好的临床疗效和安全性。本试验由北京协和医院王晓军教授牵头，中国15家中心共同参与，共入组325名受试者。3期临床试验初步数据显示，经去氧胆酸注射液治疗后，受试者颏下脂肪堆积较安慰剂组有显著性改善。颏下脂肪堆积往往影响面部外观。目前，治疗颏下脂肪堆积的主要方法是传统的抽脂手术，但术后恢复期长，存在并发症风险。去氧胆酸注射液俗称“溶脂针”，主要用于改善成人颏下脂肪造成的中至重度轮廓突出或面部过度丰满。该产品也是美国FDA于2015年批准上市的用于改善成人颏下脂肪堆积的治疗药物，并已在加拿大、澳大利亚、欧盟等20多个国家和地区上市。本次达到临床试验终点的产品由迈诺威医药研发，通过严格控控制质量标准，药品纯度＞99.9%，有望为中国广大受“双下巴”困扰的人群提供新的注射溶脂的治疗手段。迈诺威医药成立于2021年2月，致力于损容性疾病、精神疾病等严重影响患者生活质量的重大疾病领域的新药研发及产业化。该公司创始人为刘飞博士。早前迈诺威医药已完成由南京诺瑞特和立方制药共同投资的天使轮融资、由元禾原点领投的Pre-A轮融资，以及由华盖资本、醴泽资本和金浦健康共同领投的超亿元A轮融资。公开资料显示，迈诺威医药的核心技术团队具有多年的小分子创新药研发经验以及复杂制剂研发经验，擅长将药物分子化学创新与复杂制剂开发相结合，以此来解决药物递送的难点，开发出具有更佳药物递送方式的新药。该公司产品管线主要聚焦于两个领域，包括精神疾病、损容性疾病。该公司已有多款产品处理临床研究阶段，除了去氧胆酸注射液，另一款用于抗雄激素秃发的新药MI131也已经于今年4月在美国获批临床。参考资料：[1]我司去氧胆酸注射液Ⅲ期临床研究达到主要研究终点. Retrieved July 14， 2023, from https://mp.weixin.qq.com/s/NYp4g9AwM7F9tRJ3B2eOUg[2]中国首个下颌（双下巴）溶脂药Ⅲ期临床研究招募受试者. Retrieved Aug 18， 2021, from https://mp.weixin.qq.com/s/csmjswBpmXtTztHFcsH0Vw本文由药明康德内容团队根据公开资料整理编辑，欢迎个人转发至朋友圈。转发授权请在「医药观澜」微信公众号留言联系我们。其他合作需求，请联系wuxi_media@wuxiapptec.com。免责声明：药明康德内容团队专注介绍全球生物医药健康研究进展。本文仅作信息交流之目的，文中观点不代表药明康德立场，亦不代表药明康德支持或反对文中观点。本文也不是治疗方案推荐。如需获得治疗方案指导，请前往正规医院就诊。

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 . The vaccine R&D revolution has gone global. How will the lessons from Covid-19 reshape the way we study, test, produce and distribute vaccines around the world? Join me on Wednesday for a panel discussion. You can sign up at no cost here . Changes afoot at GSK Two of Hal Barron’s big R&D bets at GSK came crashing down just a couple of months after his formal departure. On top of axing its 2019 cell therapy alliance with Lyell — which it paid $250 million upfront for — GSK abandoned first-gen efforts with Adaptimmune as Tony Wood assumes full responsibility for the pipeline. In the spirit of cutting out subpar candidates, the pharma giant also scrapped filing plans for otilimab in rheumatoid arthritis after receiving disappointing Phase III results. And did we mention that vaccine chief Roger Connor is heading out ? Mixed vote for kidney drug GSK finds itself in a glass-half-full situation with daprodustat , its late-stage oral hypoxia-inducible factor-prolyl hydroxylase inhibitor. First, the FDA raised serious questions about the risk/benefit profile of the drug as a treatment for anemia due to chronic kidney diseases. Then a panel of external experts voted differently on two different patient populations, giving it a thumbs up to those on dialysis and thumbs down to those not dependent on dialysis. Unanimous thumbs down Over at the FDA’s oncology group, reviewers flagged serious concerns regarding the efficacy of Y-mAbs Therapeutics’ potential pediatric neuroblastoma treatment. Part of the problem for the FDA is that the entire application for 131I- omburtamab is based on a small, single-arm trial. The ODAC agreed, voting 16-0 against the drug’s approval citing too many data confounders. Echoing the FDA’s internal review, the adcomm noted the external control group for Y-mAbs’ pivotal study was very different from the treatment group at baseline, making it hard to draw any conclusions. The first victim of IRA? Pharma execs are still talking about the ramifications they see for President Biden’s Inflation Reduction Act — which empowers Medicare to negotiate drug prices — in their Q3 earnings. Alnylam Pharmaceuticals , the pharma market’s leader in RNAi therapies, revealed it would scrap plans to launch a Phase III trial for vutrisiran in the rare Stargardt disease and said it made the decision to avoid price negotiations. Sanofi CEO Paul Hudson said it will likely “create significant uncertainties” and “artificially influence future R&D decisions,” although he also does predict an immediate impact. Can RNA editing tool track cells, too? It’s just been a few years since biotech startups publicized the potential of ADAR in editing RNA for therapeutic use, but researchers have already found a new use for it. A group of collaborators out of the Broad and MIT created a system known as RADARS — reprogrammable ADAR sensors — which can detect and control translation of selected proteins. According to the researchers, their new platform has broad applications from studying cells to tracking RNA therapies. https://endpts.com/broad-and-mit-scientists-repurpose-hot-rna-editing-tech-as-radar-with-uses-in-cancer-and-brain-research/ PREMIUM – As work halts, families behind gene therapy seek control Families affected by the ultra-rare but deadly condition Leigh syndrome — formed the Cure Mito Foundation and raised $1 million to spark a gene therapy. Taysha Gene Therapies advanced the drug program. But in March, the biotech paused development, and when families tried to get venture investors to take over, Taysha asserted intellectual property rights in killing the plans. The situation raises tangled questions over how much say families should have after sparking research that’s later halted, as Jared Whitlock’s In Focus story explores . Two notable drugs cross FDA finish line It took years of sorting through failed trials to find the right dosing regimen, but AstraZeneca finally landed an approval for its CTLA-4 inhibitor. Imjudo — better known as tremelimumab , or treme — is approved in combination with Imfinzi for a type of unresectable liver cancer, and the company says the pricing will be “comparable” to other combos in this space. Meanwhile, J&J scored accelerated approval for Tecvayli ( teclistamab ), a BCMA-directed bispecific antibody, looking to bring a new option for patients who’ve tried multiple treatments. DEALS A few weeks after balking at a buyout offer, Myovant Sciences managed to sweeten the deal. Sumitomo Pharma , a majority owner of the biotech with a 52% stake, is paying $1.7 billion to buy out the remaining shareholders at $27 per share — up from its previous bid. The deal centered around Myovant’s two approved products, one for prostate cancer and the other to treat heavy menstrual bleeding associated with uterine fibroids and endometriosis. https://endpts.com/sumitomo-clinches-myovant-buyout-after-upping-offer-to-2-9b/ Almost two years after Agios sold its oncology unit to French pharma Servier in a $1.8 billion deal, Agios is letting go of its last link to one of the old medicines it made its name on. It went ahead and sold its rights to 5% royalties on US net sales of Servier’s Tibsovo ( ivosidenib ) to Sagard Healthcare Partners for a one-time payment of $131.8 million. The team at struggling PhaseBio is pulling out all the stops to stop development investor SFJ Pharmaceuticals from laying claims to its FDA-bound blood drug. The biotech filed for Chapter 11 bankruptcy protection , looking to set up a quick auction of the therapy to the highest bidder — and it’s lined up an unnamed pharma company to serve as a stalking horse bidder. Syncona is bringing a gene therapy player into its fold for a song. The UK life sciences investor paid $23.5 million to buy out Applied Genetic Technologies Corporation , also known as AGTC, which got started back in 1999 but still has no approved therapies. The hope is that will change, as Syncona helps push its lead candidate in X-linked retinitis pigmentosa into late-stage trials. On the back of its Covid-19 success, Moderna is reportedly one step closer to securing a new deal for other serious infectious diseases. Bloomberg reported that the biotech is nearing an agreement with the US government to develop vaccines for Ebola and additional viruses considered to be threats. R&D Mitch Gold’s plans to revive CD28 as a target and push the envelope on cell therapy 2.0 crashed into a fresh safety issue. A second patient died from cardiogenic shock after receiving one dose of Alpine Immune Sciences’ davoceticept plus Keytruda in a trial. Now Alpine will abandon the drug program and switch gears. Two decades after the FDA first approved fulvestrant to treat a type of breast cancer, AstraZeneca spotlighted two new drugs that showed promise when added to or pitted against it. In separate trials involving different subsets of breast cancer patients, the oral SERD camizestrant and the AKT inhibitor capivasertib both spurred improvements in progression-free survival. Novartis took another stride as it tries to break into a rare disease field that AstraZeneca subsidiary Alexion has dominated for years, reporting that its oral drug iptacopan bested anti-C5 therapies on increasing hemoglobin levels in a Phase III trial for paroxysmal nocturnal hemoglobinuria patients, many of whom remain anemic despite current treatment. Nuvalent set out to show that by leveraging structure-based drug design and a bit of chemistry whiz out of its Harvard founder’s lab, it can hit well-known cancer targets in ways that no others can. First-in-human data suggest its lead drug can indeed spur responses in a group of ROS1-mutant non-small cell lung cancer patients who’ve exhausted options. AstraZeneca has been looking to give itself an edge against other rival treatments in eosinophilic indications, such as GSK’s Nucala , but an initial readout from a Phase III trial may now blunt that approach. Fasenra failed to alleviate difficulty swallowing , one of the two dual-primary endpoints in eosinophilic esophagitis. It’s still analyzing the data. In May, Tricida announced it was stopping its Phase III trial for the chronic kidney disease drug veverimer early due to “administrative reasons” — namely it didn’t have enough cash. Now that it’s wrapped up the study, Tricida reports the drug made virtually no difference in preventing death or severe disease compared to placebo. Vaxcyte , a scrappy California biotech with fewer than 150 employees, says it’s ready to take on Big Pharma’s heavy hitters in pneumococcal shots. Touting Phase I/II data showing its 24-valent vaccine was just as safe as Pfizer’s recently approved Prevnar 20 — a 20-valent vaccine — the biotech also highlighted greater immune responses on multiple strains. It now plans to move into Phase III, with data expected in 2025 at the earliest. While J&J’s Janssen previously reported that roughly 60% of moderate to severe ulcerative colitis patients responded to an IV formulation of Tremfya , the company’s now suggesting that a follow-on subcutaneous dose was able to boost response and bring the total responder rate up to 80% . Patients with the rare disease NMOSD have attacks or relapses that may cause new onset of a range of symptoms or worsening of symptoms. AstraZeneca spelled out Phase III data showing that Ultomiris , a star drug from its Alexion group, can stave off those attacks and drastically lower the risk of relapse. AstraZeneca , through its rare disease group Alexion , revealed data from the Phase III open-label CHAMPION-NMOSD trial Thursday morning. In May, AstraZeneca reported the primary endpoint, which was time to first relapse, had been met in the trial. Q3 EARNINGS Buried in Novartis’ third quarter report were a few key indication drops . First, Novartis is no longer planning to submit tislelizumab for FDA approval in first-line nasopharyngeal cancer or first-line non-small cell lung cancer alongside chemotherapy — marking two more US regulatory setbacks for the PD-1 inhibitor from BeiGene . In addition, it is dropping the liver transplant indication from its iscalimab program. During Novartis’ Q3 call, CEO Vas Narasimhan emphasized he’s “willing to be patient” as he continues his mission to reshape Novartis and makes final arrangements to spin off generics unit Sandoz . While he’s still looking for deals in the sub-$3 billion to $4 billion range and a “broad range of licensing opportunities,” he made clear he won’t jump for just anything. One of the key programs that inspired Sanofi’s $2.5 billion buyout of Synthorx in late 2019 is now the subject of a $1.6 billion writedown. Sanofi disclosed in its Q3 earnings that it’s stopping Phase II platform trials for SAR444245 , an IL-2 candidate that it had hoped would serve as a next-gen foundation of the oncology franchise. An early look at the data, it said, suggests efficacy that’s “lower than projected.” It’s going back to Phase I/II. Does Merck have everything it needs for a successful pipeline? In short, no, CEO Rob Davis told investors and analysts during the company’s Q3 call. But he’s got his eye on “a list of potential places to play” when it comes to M&A. In typical pharma CEO fashion, he kept short on the details, vaguely admitting that “our urgency on business development has not changed.” AbbVie’s Q3 results and earnings call show a company bracing for what could be steep Humira losses with the coming of biosimilar competitors early next year, even as the rest of its immunology franchise outpaces initial expectations. It has signaled that it expects about 45% erosion of its megablockbuster Humira franchise in 2023. Bristol Myers Squibb’s Q3 numbers were down on the latest quarter, but execs are looking to stay the course, maintaining overall 2022 revenue guidance in light of generics eating away at the profits of megablockbuster Revlimid . And they’ve still got their eyes on BD opportunities as they look to grow the company. Takeda projected optimism in its first-half fiscal earnings call across its portfolio, announcing a boost in peak sales estimates for its already blockbuster IBD med Entyvio along with positive news on its dengue vaccine Qdenga and celiac disease pipeline. The positive outlook punctuated overall sales growth on first-half revenue of $13.6 billion, up 5.5%. While Biogen’s Q3 revenue dipped by 10% versus the prior year, the company focused its earnings call on two bright prospects — recently unveiled positive results for lecanemab , its anti-amyloid Alzheimer’s follow-up to Aduhelm , and its potential ALS drug tofersen. The FDA has until Jan. 6, 2023, to decide on lecanemab’s accelerated approval. Despite rumors swirling around a potential buyout, Seagen is focusing on good news for its key drugs while continuing to search for a more permanent CEO. That includes Padcev , with positive bladder cancer data at ESMO, and HER2 drug Tukysa , which execs say did well even as Enhertu entered the competitive space. CORONAVIRUS Looking back at the pandemic so far, it’s easy to spot the holes in the US clinical trial research infrastructure. To fix that, the White House’s Office of Science and Technology Policy, with a newly sworn-in director, Arati Prabhakar , announced plans to ensure that coordinated and large-scale clinical trials “can be efficiently carried out across a range of institutions and sites to address outbreaks of disease and other emergencies.” Recent use of Pfizer’s blockbuster Covid-19 antiviral Paxlovid has declined sharply since this summer, plunging by about half, according to federal data. But this decline, which comes amid a parallel drop in cases, means states now have more supplies ready to go for this winter. For its part, Pfizer said it’s focused on ensuring supply and monitoring resistance. The antiviral will become the first treatment studied by the NIH for long Covid as part of the NIH’s $1 billion RECOVER program, with researchers trying to figure out the cause of the condition and a way to treat it.The FDA is changing up its marketing rules for emergency use Covid treatments. Six drugmakers can now more broadly promote their Covid therapies, including Pfizer’s Paxlovid and AstraZeneca’s Evusheld . However, that doesn’t mean the companies are ready to roll out new ads. https://endpts.com/fda-loosens-marketing-rules-for-authorized-covid-drugs-but-will-it-move-the-needle/ CELL/GENE TX Half a year after Taysha Gene Therapies laid off 35% of its staffers and paused the bulk of its R&D work — devastating the families behind them — the Dallas crew secured a partner in Astellas — and about $50 million in cash — to support two main programs remaining in the pipeline. In exchange, Astellas will acquire 15% of the biotech plus an option to license the drugs, and Paul Peter Tak’s oncolytic virus startup, Candel Therapeutics , is jumping head-first into a new partnership with Carl June’s lab at Penn to see if the herpes virus can boost the effectiveness of CAR-T therapies. The idea is to penetrate the tumor microenvironments that often keep drugs out, and pave the way for CAR-Ts to kill cancer cells. Biopharma companies debating whether or not to start developing new gene therapies for neurodegenerative diseases — a historically difficult field to crack — will now have more advice from the FDA to help with preclinical testing and clinical trial design, among other topics. The final FDA guidance includes new clarifications on the recommendations regarding the use of tumor-forming cell lines, comparability studies and crossover designs for clinical trials. LAW Keen to protect its blockbusters, Novartis filed yet another federal court complaint in an attempt to drive off Entresto generics. Viatris and Mylan are among Novartis’ latest targets, as well as Alembic Pharmaceuticals , Crystal Pharmaceutical , MSN Pharmaceuticals and Nanjing Noratech Pharmaceutical — which are all trying to bring Entresto generics onto the market. Gilead’s hoping for a swift end to its HIV patent battle with HHS, filing for a summary judgment to dismiss the case without a trial. Firing back at claims that Truvada and Descovy infringed on government-owned patents, the company said there are “critical holes in the government’s evidence,” and argued that the government lacks authority to sue. More than 18 months after agreeing to pay $600 million to settle opioid marketing claims, McKinsey reached a settlement with a number of school districts and local governments. The consulting firm, which worked with opioid makers such as Purdue Pharma on how to market their products, is still facing other claims. PHARMA Four months after the US Supreme Court handed down its Dobbs decision, overturning the right to an abortion, dozens of women across the pharma industry aren’t done fighting. A group dubbed the Biotech Sisterhood released a letter — signed by more than 200 biotech, pharma and investment execs — calling for action to support reproductive rights . Regeneron and Bayer’s blockbuster eye drug Eylea was given six months more protection from competition — now extending into the first half of 2024. The FDA granted the blockbuster VEGF inhibitor an extension of pediatric exclusivity , based on new data on retinopathy of prematurity, or ROP, in preterm infants. Pharma’s lobbying expenses reached record heights last year — and according to the latest reports, the industry is on track to top those numbers in 2022 . In the first three quarters, pharma companies spent a total of $281 million on lobbying, approaching last year’s total of $350 million. PhRMA was among the groups that saw a decent uptick in spending last quarter. PEOPLE Almost four years after Genentech first accused a former top scientist of stealing trade secrets, she is going to prison. Xanthe Lam and her husband, Allen Lam , were both handed the same sentence of six months imprisonment and $10,000 in fines for their roles in an illicit scheme to benefit Taiwan’s JHL Biotech with confidential Genentech documents. UK biotech Mereo BioPharma finally reached a truce with its largest stockholder Rubric Capital Management after the investor fought for months to shake up its board and explore alternatives for its pipeline. It appears that Mereo has acquiesced to some of Rubric’s demands, placing four members on the board. As it reviews plans for developing a plant-based vaccine for Covid-19, Medicago’s US subsidiary Medicago USA filed a WARN notice in North Carolina, disclosing that 62 employees at its manufacturing facility in Durham will be out of a job within two months. Oncolytic viruses — viruses that can selectively replicate in cancer cells and kill them — have been steadily attracting investment and curiosity. However, for the most part, those candidates have not quite panned out to the extent their backers had hoped. But with former Summit CEO Glyn Edwards on board , VacV Biotherapeutics claims it can actually meet that bar. FINANCING Recursion Pharmaceuticals discreetly shut down work on one of its clinical programs, tucking in a word in SEC filings that it will end development on REC-3599 , a drug candidate for GM2 gangliosidosis. CEO Chris Gibson told Endpoints News that the move will help the company focus more on its oncology work. The news came at the same time as a $150 million private placement. A year ago, Alto Neuroscience came into the game with a $32 million Series A and plans to launch three Phase IIa trials for several psychiatric disorders, including treatment-resistant depression and PTSD. Now the company, founded by Stanford neurologist Amit Etkin , has closed a $35 million Series B to continue testing its biomarker-driven approach. Days after giving the world a peek at data for its 24-valent pneumococcal vaccine, Vaxcyte raised a whopping $600 million by selling 15 million shares in a public offering to take it forward in a space dominated by Big Pharma. On the other end of the spectrum, Taysha went for a stock sale that brought in $28 million to fund gene therapy programs still in the pipeline. After securing an $80 million credit facility in the summer, California’s Gritstone bio is making another financial move as it lifts the cover on some vaccine trials. The PIPE financing is expected to net the biotech around $45 million to advance its vaccines, including the self-amplifying mRNA candidates against SARS-CoV-2 it just claimed a win on. Diffusion Pharmaceuticals is now looking at all its options to keep itself going , even if that means selling core company technology or even the company itself. With cash running low, the tiny Virginia biotech, which has been focused on oxygenation to treat hypoxia, says it will review possible strategic opportunities to enhance stockholder value. The speed bump that little PTC Therapeutics ran into with its Huntington’s program didn’t stop Blackstone from sealing a deal to invest $50 million in the company and offer it up to $1 billion in loans. The debt will take a few different forms, but perhaps most significant is the $500 million the biotech can tap to “support business development opportunities” Blackstone agrees on. STARTUPS Lieping Chen — the I/O researcher whose early work established the PD-1/PD-L1 as a cancer target — is back with a new biotech with a new take on getting T cells into unresponsive tumors. Specifically, Normunity boasts of a screening platform that will find proteins responsible for the locking mechanism keeping T cells out. It is launching out of stealth with a $65 million Series A. Actuate , a Texas biotech trying to treat various cancers, including refractory ones for pediatric patients, is on a winding financing journey, SEC filings reveal. Setting out to raise $50 million after bringing in less than expected in the last round, it’s secured at least $11 million from 30 investors so far. It also just announced three new members to its scientific advisory board. MARKETINGRX Whatever Meta and Mark Zuckerberg may have to say, the medical metaverse is already here, digital experts say. And that blending of real and virtual life in the medical metaverse is shaping the future of medicine and healthcare — even if the word itself proves a bit of a hard sell. So what does it mean for pharma marketers? Endpoints MarketingRx editor Beth Bulik explores . Genentech wants to do more than just shine a light on the health inequities faced by Black and brown people. Through a short one-minute film tracing the health system experiences of a Black woman from childhood through adulthood, its new “Question Reality” ad campaign hopes to center tough questions and call out the systemic racism fueling US health inequities. Broadway actor Tommy Brabcco laid out his professional struggles with asthma in a 10-minute video for Sanofi and Regeneron’s Dupixent “LungZone” campaign as a spokesperson for the medication he now uses, speaking about how he managed his condition before getting his asthma under control. He joins a group of five social influencers already working on the campaign that launched last year. “Peeing in a cup sucks.” That’s the headline — and the uncomfortable truth — in one of Aurinia Pharmaceuticals’ new campaign ads, a candid series speaking to lupus nephritis patients in a “candid and real” way and encouraging them to prioritize doctor visits . Because as it also points out in the same ad: “But kidney failure is way worse.” A lot has changed in the world since Bristol Myers Squibb first introduced its campaign on cancer survivorship in 2019. However, BMS is continuing to center personal experience in its “Survivorship Today” campaign, featuring spokesman and actor Sterling K. Brown often as an interviewer speaking with patients about what it’s like to live with cancer. Cancer, specifically breast cancer, is the topic for Pfizer’s second season of its “Science Will Win” podcast; Gilead’s Kite signed on to sponsor national ‘Light the Night’ fundraisers for blood cancer patients; The Ad Council partnered with former drug dealers to raise awareness about fentanyl , including naloxone treatment; and more news can be found in the MarketingRx roundup . FDA+ By the time Gilead bought out German biotech Myr and its hepatitis delta virus candidate for $1.7 billion, the drug already had an EU authorization and US approval seemed all but a done deal. But the FDA quashed those hopes with a complete response letter on bulevirtide over concerns about the “manufacture and delivery” of the drug. When does a failed confirmatory trial evaluating overall survival not amount to a request from FDA to pull an accelerated approval for a cancer drug? That’s the situation right now for Jazz Pharmaceuticals’ Zepzelca , a second-line treatment for adults with metastatic small cell lung cancer. In denying a petition to withdraw the drug , the FDA made the point that the trial didn’t exactly cover what the approval was for. Seres Therapeutics is finally at the FDA’s doorstep with a microbiome candidate after years of ups and downs. And the FDA granted priority review to its BLA for SER-109 in preventing recurrent C. difficile infection based on data readouts from two studies. An approval here would vault the biotech ahead of heavyweights and other microbiome players in this field. Following the US’ lead, the EMA is cutting back on the use of JAK inhibitors for some patients over a suite of safety concerns. The agency’s safety committee issued new guidance recommending that a group of JAK inhibitors used for chronic inflammatory disorders is only used in certain at-risk patients if no alternatives are available. After setbacks and delays, the Swiss biotech Santhera says it has what it takes to steer its treatment for Duchenne muscular dystrophy past the FDA. Santhera, along with ReveraGen BioPharma , completed the rolling submission for an NDA to US regulators and is seeking a priority review for vamorolone to treat Duchenne based on Phase IIb data. In a new setback for Paris-based Ipsen , the FDA is postponing an adcomm meeting that was set for Oct. 31 to review new information on the company’s previously spurned potential treatment of patients with fibrodysplasia ossificans progressiva, an ultra-rare genetic disorder. A new meeting date has yet to be set and it remains to be seen whether this will delay its PDUFA deadline too. MANUFACTURING Only a few weeks after the FDA recognized a shortage of Adderall , another crucial drug is in low supply : the antibiotic amoxicillin . According to the American Society of Health System Pharmacists’ drug shortage list, three manufacturers are posting shortages of the oral version of the drug. The list includes Hikma Pharmaceuticals , Teva and Sandoz . Ireland has become a hot spot for major pharmaceutical manufacturing developments this year, and Pfizer might be the latest to get in on the action. The pharma giant is reportedly planning to invest $987 million on a manufacturing facility at its Grange Castle site in the Irish capital of Dublin. As Pakistan faces a serious health crisis caused by major flooding, GSK is drawing back on the production of a common pain medicine in the country. In a letter to Pakistan’s stock exchange, the pharma explained that the price for paracetamol , the raw ingredient for its pain medication Panadol , is “debilitating” and continuing production would not be sustainable for the company. As Fujifilm Diosynth continues its expansion drive in Europe, the company is also moving ahead with a major project in the Lone Star State. The company broke ground on a $300 million , 138,000-square-foot expansion at Fujifilm’s GMP manufacturing facility in College Station, TX, that makes vaccines and advanced therapies. It’s slated to open by 2024. As part of its investment in manufacturing infrastructure in its home state of Indiana, Eli Lilly committed a total of $92.5 million to Purdue University to establish a new pharmaceutical manufacturing scholarship program as well as renew strategic research collaborations between Purdue and Lilly. With help from the local government, the CDMO Curia is kicking off a $100 million expansion in Albuquerque, NM. The project will see Curia install a new fill-finish manufacturing line for injectable medicines as well as other capabilities to make and distribute smaller-batch advanced therapies. The fill-finish line is expected to be up and running by 2025. Nephron Pharmaceuticals’ contract manufacturing facility in South Carolina, which makes a saline solution to help replenish lost water and salt, has been given a warning letter from the FDA over several issues related to cross-contamination and other quality issues. According to regulators, the company failed to properly investigate why this happened. Indian generics manufacturer Aurobindo is having to pull another product off the shelves. According to the FDA, the company’s US branch, Aurobindo Pharma USA , issued a voluntary recall of two batches of the heart medication Quinapril . The recall was issued over a “Nitrosamine Drug Substance Related Impurity” above the proposed limit. Only a month after the FDA inspected Catalent’s site in Indiana, a site in Europe similarly received an inspection report from US regulators , this time with nine observations. The Form 483 cites issues with air filters in aseptic areas, deficient changes to the HVAC system inside of the clean rooms used for filling, as well as equipment issues. Generics giant Jubilant has one of its manufacturing sites under the FDA’s microscope. A 14-page Form 483 inspection report from late July and early August revealed six major observations at the Jubilant manufacturing site in the village of Sikanderpur Bhainswal in northern India, including that it had not reviewed failures in drug batches. Dutch CDMO Symeres acquired Exemplify BioPharma , a CRO that provides drug development services, formulation development and CMC services to customers; Meanwhile, Cambrex is planning several expansions in the Midwest; A French viral vector manufacturer will team up with a manufacturing service provider on cell and gene therapy offerings — get all the details in the Manufacturing roundup . DON’T MISS Even back in the day as the singer for Chester French , a two-man indie pop group that sporadically flared into public sight, DA Wallach had a rep as someone who knew people. Those connections have earned him a place in the venture world as a “visionary young investor.” Now Wallach’s going to give it a go in biotech, joining forces with longtime biopharma research vet Tim Wright to launch a new fund dubbed Time BioVentures , with $100 million to start. Swiss billionaire Hansjörg Wyss made his largest donation yet to the institute at Harvard University that bears his name. His $350 million gift to the Wyss Institute for Biologically Inspired Engineering brings the total donated to $731 million. It also comes as the institute plans to move to new headquarters and its biotech spinouts have been buzzing with activity. Just a month after shipping out the initial batch of its homegrown nanoparticle Covid-19 vaccines, South Korea’s SK bioscience signed a deal with the Coalition for Epidemic Preparedness Innovations to try out a different technology platform: mRNA. CEPI is offering the company up to $40 million for early development of an mRNA vaccine platform, including two initial projects, with another $100 million on the line if it moves into late-stage trials. Pacific Biosciences , or PacBio for short, made its name in long-read DNA sequencing, filling in a niche market where typical short-read DNA sequencers, like the ones on which Illumina built its dominance, could not go. But now, PacBio wants to take on Illumina directly, with plans to release a short-read sequencer known as Onso .