Thursday, March 28, 2024

Teva On Track for Seventh Straight Day of Gains

(3/27, Nilanjana Basu, Seeking Alpha) ...According to SA analyst DT Invest, "Teva Pharmaceutical is deeply undervalued, trading at a 77% discount per my calculations, and the new CEO's turnaround plan looks promising." Analyst Stephen Ayers spoke on the recent Q4 earnings of the company and said, "Teva's Q4 earnings show significant growth; the 2024 outlook is optimistic with revenue projections of $15.7-$16.3 billion, focusing on key products."... Full

Henlius Reports First Fully Profitable Year After Past Losses

(3/27, Adam Zamecnik, Generics Bulletin) ...Shanghai Henlius Biotech has achieved its first full year of profitability in 2023 on the back of increased sales and growing sales volume, marking a change from the last two years' of reported losses. The Chinese company reported a net profit of RMB546m ($75.72m) in the reporting period that ended with the turn of the year as the business continues adding further milestones to its momentum... Global Sub. Full

Sanofi Inks 3 Distribution Pacts in India and Korea for CNS Drugs and Vaccines

(3/27, Fraiser Kansteiner, Fierce Pharma) ...Sanofi has inked deals with India's Cipla and Dr. Reddy's Laboratories, as well as South Korea's SK Bioscience, to help sell its central nervous system drugs and vaccines in those countries. Concerning Cipla, the Indian manufacturer is set to market six Sanofi central nervous system medicines, including the leading epilepsy med Frisium. Sanofi will continue to own, import and manufacture its full spectrum of CNS products, both in-country and internationally, according to a release... Full

Big Plans Ahead: Cipla Looks for Shot in the Arm in Niche Areas

(3/27, Sohini Das, Business Standard) ...Mumbai-based Cipla is evaluating acquisition in areas such as oncology, mental health, obesity, wellness, genomics, and diagnostic services, Umang Vohra, managing director and global chief executive officer, told Business Standard...Tuesday's deal is to distribute Sanofi India's six CNS brands, including Frisium, a leading product in the anti-epileptic medication category. Analysts say as Cipla aims to move from being a pharma company to being an integrated health care player, it is evaluating opportunities in these areas... Full

Celltrion Adds 20-mg Dose Option to its Humira Biosimilar

(3/28, Pulse) ...Celltrion Inc. announced on Thursday the launch of a 20 mg dose of Yuflyma (adalimumab-aaty), a biosimilar of the monoclonal antibody Humira, in the United States. The new dose is for pediatric use and will offer greater dosage flexibility and tailored drug administration for patients alongside the 40 mg and 80 mg concentration options that are already on offer... Full

AstraZeneca Plans Independent Drug Supply Chains for US and China, CEO Says

(3/27, Angus Liu, Fierce Pharma) ..."We have a very large supply chain, and we are organizing ourselves so that we can actually supply the United States and Europe independently," AstraZeneca CEO said in an interview with Bloomberg on the sidelines of the Boao Forum for Asia in China. "And we also are building our presence here in China, so we can actually supply Chinese patients independently."...It's probably unrealistic to expect AZ—or any large pharma company—to fully split its supply chains given the specialized nature of the industry and shared suppliers of starting materials and ingredients. But companies are likely to continue planning manufacturing investments in both major markets... Full

Zydus Lifesciences Up Marginally Despite 4 Observations from USFDA

(3/28, Money Control) ...Zydus Lifesciences share price was up marginally in the early trade on March 28 despite the company receiving four observations from United States Food and Drug Administration...USFDA inspected at firm's Onco Injectable manufacturing plant in Ahmedabad from March 18 to 27. The inspection closed with four observations and there were no data integrity related observations, company said. The company will closely work with the USFDA to address the observations, it added... Full

Amneal Pharmaceuticals, LLC. Issues a Nationwide Voluntary Recall of Vancomycin Hydrochloride for Oral Solution USP, 250mg/5mL, Due to the Potential for Some Bottles to Be Super Potent Which May Be Harmful

(3/27, Amneal Pharmaceuticals) ...Amneal Pharmaceuticals, LLC. Bridgewater, New Jersey, is voluntarily recalling 4 lots of Vancomycin Hydrochloride for Oral Solution, USP, 250 mg/5mL packaged in 80 mL, 150 mL, or 300 mL pack sizes, to the Consumer Level. Some bottles may have been overfilled which can result in an over potent dosing regimen...The error occurred during the manual bottle filling stage of manufacturing... Full

Reuters Pharma USA 2024 - Day 2

(3/27, Jonah Cornstock, Pharma Phorum) ...Wednesday brings much more Cell and Gene Therapy content, but we'll also dip into the Marketing and Commercial tracks, looking at real-world evidence, value-based care, and omnichannel marketing. The day will include presentations from the Patient Access Network, AstraZeneca, Novartis, Otsuka, and Novo Nordisk. And we'll wrap up with some closing keynotes dealing with the important topic of health equity... Full

ADHD Medications Linked to Weakening of Heart Muscle

(3/27, Ernie Mundell, HealthDay News) ...ADHD stimulant medications like Ritalin or Adderall appear linked to a heightened risk for cardiomyopathy (a weakening of the heart muscle), and the risk grows with time, new research shows. However, researchers were quick to note that cardiomyopathies are rare in the young, and even with ADHD medication use the absolute risk to any one patient remains very small... Full

Biden vs Trump On Drug Pricing And Unfinished Business

(3/27, Cathy Kelly, Pink Sheet) ...President Joe Biden's ability to take on major new drug pricing reforms in a second term will depend on the makeup of Congress. Former President Donald Trump, on the other hand, may want to put his own stamp on drug reform if he is elected. Trump could return to 'unfinished business' in the form of the international reference pricing policy for Medicare Part B drugs known as the Most Favored Nation Model... Sub. Req'd

Sanders Calls for Novo Nordisk to Slash Ozempic, Wegovy Prices

(3/27, Lauren Sforza, The Hill) ...Sen. Bernie Sanders (I-Vt.) called on pharmaceutical manufacturer Novo Nordisk to slash prices for two of its drugs Wednesday, citing a new study on the costs to manufacture the medications. The research found that a weekly injection of semaglutide — which is the generic name for Ozempic — can be manufactured at a cost between $0.89 and $4.73 per month... Full

Novo's $1,000 Diabetes Drug Can Be Made for Under $5 a Month

(3/27, Robert Langreth and Madison Muller, Bloomberg) ...Novo declined to provide production costs for Ozempic and Wegovy, its related drug for obesity. The company said it's making significant investments to ensure that the public has access to its widely popular drugs. It's making about $6 billion in capital expenditures and spending $11 billion to acquire production facilities from Catalent Inc. as part of those efforts, according to an emailed response to questions... Full

Valsartan Adulteration Lawsuit Sees Most Claims Head to Trial

(3/27, Shweta Watwe, Bloomberg Law) ...Labels identifying drugs as valsartan constituted express warranties about the medications' safety, but whether manufacturers breached the warranty depends on disputed facts, a federal judge said ahead of a bellwether trial in litigation alleging generic blood pressure medications were contaminated by a carcinogenic substance...Consumers and insurers from many states sued ingredient supplier Zheijiang Huahai Pharmaceuticals Ltd., Teva Pharmaceuticals USA Inc., Torrent Pharmaceuticals Ltd., and others... Sub. Req'd

Industry Protests FDA Plan To Clear Guidance Backlog By Skipping Comments

(3/27, Jessica Karins, InsideHealthPolicy) ...Key industry groups are objecting to FDA's plan to tackle its decades-old backlog of draft guidance documents by sometimes skipping opportunities for public comment, and they offer a number of other ways the agency could overhaul its guidance procedures. While it made sense to sidestep public comments to expedite guidance during the COVID-19 pandemic, industry says, the practice shouldn't carry over post-pandemic... Sub. Req'd

AstraZeneca Sues Arkansas Over the Role of Pharmacies in a Federal Discount Drug Program

(3/27, Ed Silverman, STAT Plus) ...AstraZeneca filed a lawsuit seeking to block an Arkansas law that requires the company to ship its medicines to any pharmacy working with hospitals participating in a controversial federal discount program. The move comes less than a month after a U.S. appeals court upheld the same law, but the company is trying to make a different argument in hopes of stopping other states from pursuing similar laws... Sub. Req'd

AstraZeneca Sues to Block Arkansas Contract Pharmacy Law

(3/27, Nyah Phengsitthy, Bloomberg Law) ...That suit was brought on by leading drug lobby group, the Pharmaceutical Research and Manufacturers of America. AstraZeneca made clear in this week's complaint that it is not a member of PhRMA and "does not rely here on the claims asserted in that litigation." AstraZeneca, instead, argued Arkansas' law is unconstitutional, is preempted by federal patent law, violates the contracts clause of the US Constitution, and violates the takings clauses of the US Constitution and the Arkansas Constitution... Sub. Req'd

Could RI Move to Control Prescription Drug Costs? What This Bill Would Do.

(3/28, Katherine Gregg, The Providence Journal) ...The eight-page bill had its own enthusiastic backers, including the AARP, which noted that several states have already enacted similar legislation, including Maryland, Colorado, Washington, and Minnesota. But it also prompted warnings, including those raised by the cystic fibrosis advocacy group about "prescription drug affordability review boards" that do "not address the true levers of affordability that govern healthcare costs for Americans, which are out-of-pocket costs." "Eliminating out-of-pocket costs can meaningfully lower healthcare spending without compromising patients' access to lifesaving medications and overall wellbeing," the group argued... Sub. Req'd

Pharmacy Deserts Threaten Iowa's Picture of Health

(3/27, Cheryl Tevis, Iowa Capital Dispatch) ...Data from the University of Iowa's Carver College of Medicine reinforces the Iowa Pharmacy Association survey. Michael Andreski, RPh, PhD, associate professor of pharmacy at Drake University in Des Moines, has surveyed Iowa pharmacies, finding that the state lost almost 14% of its pharmacies between 2008 and 2022. He says this decline is hitting independent pharmacies harder, especially in rural communities. Andreski is using his survey results to design pharmacy desert maps to convince Iowa legislators of the need for serious action to stem these losses... Full

Nessel Announces New Opioid Settlement Website

(3/27, Jon King, Michigan Advance) ...Michigan Attorney General Dana Nessel announced the new website on Wednesday, which she said would serve as a one stop shop for both residents and local units of government searching for information about the $1.6 billion settlement, half of which will be distributed directly to municipal governments and the other half to the state government's specially designated fund, The Michigan Opioid Healing and Recovery Fund... Full

Medicines For Europe Responds To New EU Biotech Initiative

(3/27, Adam Zamecnik, Generics Bulletin) ...Medicines for Europe's Biosimilar Medicines Group has called on the European Commission to bolster its efforts in advancing the field as part of the bloc's recently announced biotech and biomanufacturing initiative...The Biosimilar Medicines Group highlights the need to sustain European leadership in the international biotech ecosystem that will allow it to invest in improvements in manufacturing capabilities and biotech R&D that will use new technologies... Global Sub. Full

'Don't Compromise The Pharma Innovation System,' Says Outgoing IFPMA Head Thomas Cueni

(3/27, Ian Schofield, Pink Sheet) ...Thomas Cueni is stepping down after seven years at the helm of the International Federation of Pharmaceutical Manufacturers and Associations. In an interview with the Pink Sheet ahead of his retirement, he reflects on the proposed pandemic treaty, what still needs to be done to ensure equitable access to medicines, the importance of tackling AMR, moves towards regulatory reliance – and what his post-IFPMA life might look like... Sub. Req'd

EU Regulatory Assessors Get AI Boost In Reaching Scientific Decisions

(3/28, Vibha Sharma, Pink Sheet) ...The European Medicines Agency has rolled out an artificial intelligence-enabled knowledge mining solution that will allow regulatory assessors in the EU to more easily find the information they need to help inform their scientific decisions. The tool, called Scientific Explorer, is a type of search engine that European medicines regulatory network scientific staff can use to efficiently carry out focused and precise searches in the vast range of regulatory procedure documents that are already available to them... Sub. Req'd

Biocon Becomes the First Generics Company to Get a Diabetes Drug Approval in the UK

(3/28, Hormaz Fatakia, CNBC TV 18) ...Biocon Ltd. has received approval from the Medicines and Healthcare Products Regulatory Agency UK for its complex formulation Liraglutide filed through its European partner, Zentiva. Liraglutide is a 6 mg / ml solution for injection in a pre-filled pen... Full

The World's Broken Market for Medicines

(3/27, Ian Johnston and Amy Borrett, The Financial Times) ...While doctors raise concerns about the effects of supply bottlenecks on patients, and manufacturers underline the unattractive economics of generic drugs, policymakers are discussing the geopolitical risks of Chinese and Indian supply. A goal of an upcoming Critical Medicines Act from the European Union is to reshore some supply and encourage drug stockpiling. Currently, there is little incentive for manufacturers not to source from cheap factories in Asia using just-in-time supply mechanisms...To reshore manufacturing, healthcare systems will ultimately have to pay more for their drugs, at a time when national budgets are increasingly stretched... Sub. Req'd

India IPR Realities: Pharma, Legal Heads Discuss Winds Of Change, ‘Damocles Sword'

(3/27, Anju Ghangurde, Generics Bulletin) ...Leaders from Novartis, Bayer, Sun Pharma, the Indian Pharmaceutical Alliance, Médecins Sans Frontières and Anand and Anand discuss India's evolving intellectual property rights landscape, including pre-grant oppositions, enforcement action and other realities. Concerns around evergreening, restrictions on patent-eligible subject matter and compulsory licensing were also key talking points at a recent conference in Hyderabad... Global Sub. Full

Biopharma Manufacturing ‘Turbulence' Boosts Inquiries for India-Based Providers, Local CDMO Execs Say

(3/27, Anna Brown, Endpoints News) ...India-based CDMOs have detected an uptick in biopharma client interest in their biologics and early-phase clinical offerings – and these manufacturers are accordingly adjusting their growth strategy. "There's an increase in demand. There's a lot of factors that are going on that are influencing that," Enzene Biosciences' CEO Himanshu Gadgil told Endpoints News in an interview. Enzene especially has seen an increase in small to midsize biopharma clients reaching out. "We will definitely be looking at being more aggressive in terms of our expansion plan," he added... Full

Open For Business: Sandoz's Austrian Antibiotic Facility Is Ready To Serve

(3/27, Urte Fultinaviciute, Generics Bulletin) ...As Sandoz continues to fight against antimicrobial resistance, the firm opens a new production facility in Austria, strengthening its position in Europe with a vertically integrated production network for penicillin..."Antibiotics are the backbone of modern medicine and Kundl is a testament to the resilience of European manufacturing. We are proud to further strengthen our manufacturing capabilities in Austria. This allows us to address growing demand and further strengthens our commitment to our unique European-based antibiotic production network," said Sandoz's chairman Gilbert Ghostine... Global Sub. Full

Strong Growth for Sweden's Pharmaceutical Exports

(3/27, Catherine Eckford, European Pharmaceutical Review) ...A focus on innovation and high quality is helping Sweden to strengthen its position as a key player in the global life sciences market, SwedenBIO states...With one success factor of Swedish life sciences being the export numbers, "in majority driven by AstraZeneca", Maja Neiman, Scientific Director of SwedenBIO explained to EPR that another important influence is "the high numbers and potential of [Sweden's] domestic innovation pipeline"... Full

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