Friday, April 19, 2024

Alvotech Signs U.S. Agreement to Expand Access for Newly Approved High-Concentration Interchangeable Biosimilar to Humira® (Adalimumab)

(4/19, Alvotech) ...Alvotech, in agreement with Teva Pharmaceuticals, has signed an agreement with a strategic partner to bring to the U.S. market the newly FDA approved high-concentration interchangeable biosimilar to Humira®...The current multi-product commercialization partnership between Teva Pharmaceuticals and Alvotech remains unchanged and Teva will continue to commercialize adalimumab-ryvk under the SIMLANDI® brand in the US... Full

Second Stelara Biosimilar Selarsdi Gets FDA Approval

(4/18, Inside Health Policy) ...Tom Rainey, senior vice president of U.S. market access at Teva, told Inside Health Policy the companies are in the process of finalizing the pricing of Selarsdi and declined to comment on whether it will be labeled as interchangeable with Stelara. Stelara's first biosimilar Wezlana received FDA approval in October last year with interchangeable status... Sub. Req’d

Sanofi to Overhaul US Operations of Vaccines, Cut Jobs

(4/19, Reuters) ...Sanofi CEO Paul Hudson has been trying to build investor confidence in the company's drug pipeline since he unexpectedly abandoned 2025 margin targets last October to instead boost drug development spending. The company's vaccine portfolio includes preventive shots for a common respiratory infection in infants, influenza vaccines, COVID vaccines and vaccines for infections like meningitis and tetanus... Full

Amneal, Lupin to Pay $3.4 Million in Antitrust Deal Over Xyrem

(4/18, Katie Arcieri, Bloomberg Law) ...Judge Richard Seeborg of the US District Court for the Northern District of California in a Wednesday order called the deal "fair, reasonable, and adequate" for settlement class members including insurers and beneficiaries who paid or reimbursed some or all of the purchase price for Xyrem or Xywav, a similar drug, starting from Jan. 1, 2015. Seeborg granted preliminary approval of the deal roughly a year ago... Sub. Req’d

Heard on the Street: AbbVie's Bet on a Neuroscience Drug Maker Just Got Better

(4/19, David Wainer, The Wall Street Journal) ...Notably, when AbbVie announced the $8.7 billion acquisition of Cerevel in December, the focus of the deal was the experimental schizophrenia drug Emraclidine, part of a new class of medications that target the muscarinic receptor...So it was a pleasant surprise for AbbVie and its investors that a less hyped drug for Parkinson's performed well in a late-stage study. The study showed that when Cerevel's treatment, tavapadon, is used with levodopa, a common treatment for the disease, it can improve patients' motor-symptom control... Sub. Req’d

India's Biocon Developing Its Own Version of Wegovy, Clinical Trial Likely Next Year

(4/18, Rishika Sadam, Reuters) ..."We're going to develop semaglutide for India even if it requires a clinical trial," Chief Executive Officer Siddharth Mittal said in an interview of the active ingredient in Wegovy and Ozempic. "We're striving to be in the market as one of the early players. Either it would be in 2026 or not too late after that."... Full

Biocon Signs Agreement With Biomm for Generic Semaglutide Commercialisation in Brazil

(4/19, BioSpectrum India) ...Biocon has announced the signing of an exclusive licensing and supply agreement with Biomm S.A., a specialty pharmaceutical company in Brazil, for the commercialisation of its vertically integrated drug product, Semaglutide (gOzempic), which is used to improve glycemic control in adults with type-2 diabetes... Full

Eli Lilly's Zepbound in Shortage Months After Approval

(4/18, Joseph Choi, The Hill) ...Executives for Eli Lilly told NBC News that the limited supply would last for the near term. "We are working so hard every day to make sure that we increase that capacity as fast as we can to get these medications in patients' hands," Rhonda Pacheco, Eli Lilly group vice president for diabetes and obesity, told the outlet... Full

Potential Generics Could Lower Prices for Oncology, Cardiovascular Drugs | AMCP 2024

(4/18, Denise Myshko, Managed Healthcare Executive) ...Although the GLP-1s have been in the limelight, there are other weight loss drug. One of them, Qsymia (phentermine/topiramate), is losing patent protection this year. Two companies that have filed for generic approvals. Teva is likely the first to be approved and will have a 180-day period exclusivity... Full

Consumer Trust in Physicians and Pharma Is Up, but Lower for Employers and Biotech

(4/19, Beth Snyder Bulik, Endpoints News) ...Consumer trust in the pharmaceutical industry rose five points to 54%, while trust in biotech and life sciences dipped two points to 56%, compared to a year ago...Pharma's trust increase is the latest in several years of seesawing consumer opinions — low before the pandemic, spiking up during the Covid years, and then slipping again the past two years... Sub. Req’d

Drug Shortages, Inspections In Focus At US FDA Appropriations Hearing

(4/18, Sue Sutter, Pink Sheet) ...In between many tobacco and vaping questions, US Food and Drug Administration Commissioner Robert Califf still managed to tout priorities important to drug oversight during a House subcommittee hearing on the agency's fiscal year 2025 budget request...Drug shortages, foreign manufacturing and supply chain vulnerability issues were a common, intertwined thread throughout the hearing. Califf said the FDA's budget request seeks legislative fixes that would help the agency mitigate drug shortages more effectively, including "information that we need right now."... Sub. Req’d

Patient Advocates Shred Becerra's Copay Accumulator Comments During House Hearing

(4/18, Noah Tong, Fierce Healthcare) ...Some lawmakers praised the administration's commitment to key priorities like the Medicare drug price negotiations program. At times, members on both sides of the aisle grew exasperated at Becerra's unwillingness to directly answer questions. But an exchange with Rep. Buddy Carter, R-Ga., over copay accumulators more than 90 minutes into Becerra's third day of testimony drew some of the toughest criticism yet from patient advocacy groups, leaving some to question where his loyalties lie and others wondering if he's simply uninformed on the issue... Full

Embattled Drug Discount Dispute Process Gets HHS Facelift

(4/18, Ian Lopez and Nyah Phengsitthy, Inside Health Policy) ...The Health and Human Services Department on Thursday announced a final rule (RIN 0906-AB28) that updates the administrative dispute resolution process for drugmakers and health providers participating in the federal 340B drug discount program. Under the program, drugmakers are required to discount their products to covered medical providers such as hospitals, community health centers, and others supporting low-income populations... Sub. Req’d

Biosimilar Strategy Pivotal to a Stronger European Health Union

(4/18, Medicines for Europe: The Biosimilar Medicines Group) ...As disease incidence continues to increase and patient need for biological medicines already accounts for 40% of all medicines used, the Biosimilar medicines group calls on a future looking Biosimilar Strategy for Europe... Full

Letta Report Underlines Need to Improve Equitable Access to Medicines and Support for Critical Medicines Production in Europe

(4/19, Medicines for Europe) ...Enrico Letta's Report on the Future of the Single Market highlights the need to encourage equity of medicine access, sustainable pricing and procurement models for supply and EU-wide funds for investments in medicine manufacturing in Europe... Full

UK Patients Face "New Normal" of Medicines Shortages

(4/18, The Pharma Letter) ...These shortages come at a cost to the patient and the taxpayer and, on the UK, are happening despite the National Health Service (NHS) spending hundreds of extra millions trying to mitigate the problem...That's according to a new report by the Nuffield Trust think tank and a group of academics, funded by the Health Foundation, which examined key indicators on drug shortages in the UK in the context of global problems with supply chains and the availability of key ingredients. It finds that the past two years have seen constantly elevated medicines shortages, in a "new normal" of frequent disruption to crucial products... Sub. Req’d

France Might Block Drugmaker Biogaran's Sale to Foreign Firm

(4/18, Francois de Beaupuy, Phil Serafino, Bloomberg) ...If a foreign buyer wants to acquire [generic-drug maker] Biogaran, France could activate a so-called IEF review, which allows the state to screen and possibly block potential investments by foreign companies in strategic sectors, Lescure told reporters Thursday after inaugurating a factory that makes medical gloves. "We obviously need to be able to guarantee the supply of our medicines, and for this, we have a weapon," [Industry Minister Roland Lescure] said... Sub. Req’d

Regulators Explain Process for Requesting Real-World Evidence Studies by EMA

(4/18, Ferdous Al-Faruque, Regulatory Focus) ...The document explains that when considering such requests, EMA will first consider whether the study is feasible using the Data Analysis and Real-World Interrogation Network DARWIN EU database, which went into effect earlier this year. The document also provides an overview of the types of RWE studies and how they can be used to support regulatory decision making... Full

API Price Decline Is a Mixed Blessing for Indian Pharma Industry

(4/18, The Pharma Letter) ...While the decline in some API prices is a boon to formulation players, affording them a competitive edge and potentially bolstering profit margins, it has cast a shadow over newbie API manufacturers in India... Sub. Req’d

China's API Extortion From Indian Pharma Breaking Down

(4/18, Ashwani Mahajan, Fortune India) ...The Indian government, while being vigilant, will have to make every possible effort to stop dumping in the field of APIs by China... Full

Middle East Crisis Escalation May Hurt Pharma Exports

(4/19, Teena Thacker, The Economic Times) ..."Companies like Sun Pharma, Dr Reddy's, Lupin, Torrent, and Divi's Labs are likely to suffer the most due to their significant presence in the MENA region," said Dinesh Dua, a former chairman of the Pharmaceutical Export Promotion Council (Pharmexcil). "In fact, Sun Pharmaceutical has a fully-owned subsidiary, Taro Pharmaceutical, based out of Israel which can have supply chain issues."... Full

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