Thursday, January 23, 2025

FDA Warns of Serious Allergic Reactions with Multiple Sclerosis Drugs

(1/22, Sriparna Roy, Reuters) ...The U.S. Food and Drug Administration on Wednesday warned about the risk of a rare but serious allergic reaction with the use of some multiple sclerosis drugs including Teva's Copaxone... Full

Teva's MS Drug and Generics to Add Black Box Warning for Anaphylaxis

(1/23, Ayisha Sharma, Endpoints News) ...The FDA has issued a new boxed warning for Teva Pharmaceuticals' multiple sclerosis drug Copaxone and generic versions marketed by other companies after some patients had serious allergic reactions... Full

FDA Warns About Anaphylaxis Risk With MS Drug

(1/22, Judy George, MedPage Today) ...The FDA added the boxed warning based on 82 serious cases of anaphylaxis associated with glatiramer acetate from December 1996 through May 2024. Of these, 19 cases reported anaphylaxis more than 1 year after starting treatment. The median time to onset of anaphylaxis from starting glatiramer acetate was 5 months (range 1 day-72 months)... Full | Formulary Watch

FDA: Anaphylaxis Risk Prompts Boxed Warning for MS Drug

(1/22, Diana Ernst, Rph, MPR) ...Most of the patients in these reported cases experienced anaphylaxis within 1 hour after injection... Full

Teva Price Target Raised to $30 from $28 at UBS

(1/23, The Fly) ...UBS raised the firm's price target on Teva to $30 from $28 and keeps a Buy rating on the shares. Teva, one of the firm's top picks for 2025, is a de-risked story from a fundamental perspective with an accelerating brand transition, the analyst tells investors in a research note. The firm expects Teva to announce the sale of the Active Pharmaceutical Ingredients unit with Q4 results next week, and is now modeling Austedo 2027 sales at $2.4B, with Uzedy 2030 sales at $529M... Full

Sandoz Strikes Settlement On US Binimetinib ANDA

(1/22, Dean Rudge, Generics Bulletin) ...Sandoz has agreed to deal out of US patent-infringement proceedings with Pfizer's Array BioPharma, following the generics manufacturer's earlier lawsuit stemming from its filing of a generic version of Pfizer's Mektovi (binimetinib)...Array has ongoing lawsuits against another pair of abbreviated new drug application sponsors, Alembic Pharma and Teva, over binimetinib patents...Teva in December last year, weeks before the Sandoz settlement was inked, was requesting a Delaware court to stay its case pending resolution of any appeal of a recent claim construction decision in the Alembic case... Global Sub. Full

Piramal Pharma's Critical Care Division Launches Chlorpromazine Injection in US

(1/22, Jomy Jos Pullokaran, CNBC TV-18) ...Piramal Pharma Ltd on Wednesday (January 22) said its division Piramal Critical Care (PCC) has announced the US launch of Chlorpromazine Hydrochloride for Injection, USP. The product will be available in two vial formats—25 mg/1 mL and 50 mg/2 mL—marking an expansion of PCC's generic injectables portfolio... Full

USFDA Designates Zydus' Usnoflast An Orphan Drug for ALS Treatment

(1/23, Express Pharma) ...Zydus Lifesciences announced that the USFDA has granted Orphan Drug Designation (ODD) to Usnoflast, a novel oral NLRP3 inhibitor, for the treatment of amyotrophic lateral sclerosis (ALS)... Full

Indian Drugmaker Dr Reddy's Misses Q3 Profit View On Weak Drug Pricing

(1/23, Kashish Tandon, Reuters) ...The company reported a 2.3% rise in its consolidated net profit at 14.14 billion rupees ($163.7 million) for the quarter ended Dec. 31, missing analysts' average estimate of 14.89 billion rupees, as per data compiled by LSEG. Indian generic drugmakers have been struggling with sales slowdown in the U.S. due to delayed approvals for new drug applications, lower pricing amid stiff competition and increased inspections at manufacturing facilities by the Food and Drug Administration, according to analysts... Full

J&J Stands by Sales Growth Ambitions—and Points to Potential Tremfya Boon—As Stelara Biosimilars Take Hold

(1/22, Fraiser Kansteiner, Fierce Pharma) ...Surveying the next 12 months, J&J expects to chart roughly 3% sales growth to $91.3 billion in 2025 by "overcoming headwinds associated with U.S. biosimilar entries for Stelara," as well as this year's Medicare Part D redesign and continued macroeconomic pressures in China, CEO Joaquin Duato told analysts on the call...In the U.S., where patent litigation delayed the entry of Stelara biosimilars until this year, Amgen's copycat Wezlana debuted on Jan. 1, according to reports. It will soon be followed onto the market by Stelara competitors from partners Teva and Alvotech, Fresenius Kabi and Accord BioPharma, as well as Celltrion and Sandoz... Full

Celltrion Launches Stelara Biosimilar in France, Completing Rollout in Europe Ahead of US Debut

(1/23, Kim Ji-hye, Korea Biomedical Review) ...Celltrion announced Thursday that it has launched Steqeyma (ustekinumab), a treatment for autoimmune diseases, in France, completing its rollout in five major European markets: Germany, Spain, the U.K., Italy, and France. The company plans to expand Steqeyma's availability to additional European countries later this year while preparing for its official launch in the U.S... Full

Wezlana, First Stelara Biosimilar To Hit the Market, Available Only Through Optum's Nuvaila

(1/22, Peter Wehrwein, Managed Healthcare Executive) ...An Optum spokesperson said in an email to Managed Healthcare Executive this morning that Nuvaila has exclusivity to Wezlana...An Amgen spokesperson said in an email that the company has entered into a "collaboration agreement" to manufacture Wezlana for Nuvaila and referred questions about price and distribution to Nuvalia... Full

The Big Three PBMs' 2025 Formulary Exclusions: Humira, Stelara, Private Labels, and the Shaky Future for Pharmacy Biosimilars

(1/22, Adam J. Fein, Ph.D., Drug Channels) ...For 2025, the three largest pharmacy benefit managers (PBMs)—Caremark (CVS Health), Express Scripts (Cigna), and Optum Rx (United Health Group)—have again each excluded hundreds of drugs from their standard formularies. You can find our updated counting below. As you'll see below, the combination of formulary exclusion and private labels is creating an increasingly confusing and crowded biosimilar marketplace... Full

More Insights Revealed At J.P. Morgan Conference

(1/22, Dean Rudge, Urte Fultinaviciute, Dave Wallace, and Adam Zamecnik, Generics Bulletin) ...In the aftermath of last week's J.P. Morgan Healthcare Conference in San Francisco, Generics Bulletin's editorial team brings you additional coverage of items of interest for the global generics and biosimilars industry... Global Sub. Full

Investors Lose Their Appetite for the Obesity Trade

(1/23, Hannah Kuchler and Oliver Barnes, Financial Times) ...Some investors are also unconvinced that the market will be worth the $100bn plus by the end of the decade that analysts predict. The result for now is that Novo Nordisk is no longer the most valuable company in Europe, and anti-obesity specialists have entered bear market territory. Sachin Jain from the Bank of America points to the growth potential of the market as one of the main unknowns that worries investors... Full

ICYMI: Institute for Clinical and Economic Review Announces Annual Launch Price and Access Report for 2025

(1/22, The Campaign for Sustainable Rx Pricing) ...Today, the Institute for Clinical and Economic Review (ICER) announced plans to release a new analysis annually, titled the "Launch Price and Access Report," to examine launch pricing for U.S. Food and Drug Administration (FDA)-approved treatments, their affordability, access to these treatments and the value they bring to the overall health system. The analysis will examine all novel drug approvals in the previous two years... Full

US FDA Urges Generics To Stay Engaged On Metered Dose Inhalers

(1/22, Michael McCaughan, Pink Sheet) ...Generic drug companies may worry about transitioning metered dose inhaler products to new lower global warming potential propellants, but the FDA stressed they should continue product development. ANDAs for products with LGWP propellants still cannot be submitted because it is a novel excipient. But the FDA is willing to work with generic sponsors during the pre-ANDA phases, Robert Lionberger said... Global Sub. Full

FDA Promises Imminent Guidance On Interchangeable Biosimilar Exclusivity

(1/22, Dave Wallace, Generics Bulletin) ...Long-awaited guidance setting out the US Food and Drug Administration's approach to exclusivity for first interchangeable biosimilars will be published by the end of this year, according to a 2025 guidance agenda published by the agency's Center for Drug Evaluation and Research...Other biosimilars guidance outlined by the CDER for this year includes documents on considerations for container closure systems and device constituent parts; on pediatric study plans for biosimilars; and a revised document on scientific considerations in demonstrating biosimilarity to a reference product... Global Sub. Full

Former Trump Official & CBO Director: Trump May Be Able To Modify Drug Negotiation List

(1/22, Maaisha Osman, Inside Health Policy) ...A former Trump White House official and a former Congressional Budget Office (CBO) director tell Inside Health Policy the Trump administration may be able to modify the list of drugs chosen for the second round of Medicare price negotiation, but says it might be harder do so before the Feb. 1 deadline. Other legal experts tell IHP the statute clearly outlines which drugs should be included in the program, making it unclear how the new administration could make changes... Sub. Req’d

CMMI Demos' Future Unclear After Trump Revokes Biden's Drug Pricing EO

(1/22, Gabrielle Wanneh, Maaisha Osman, Inside Health Policy) ...Stakeholders are watching to see what President Donald Trump's revocation of a Biden-era executive order on drug pricing will mean for three CMS innovation Center demonstrations spurred by the EO, but which for now appear to be continuing. Biden's CMS announced in 2023 its intention to test three models: The Medicare $2 Drug List, the Cell and Gene Therapy (CGT) Access model, and the Accelerating Clinical Evidence (ACE) model... Sub. Req’d

Warren Fires 175 Questions At Kennedy Ahead of Senate Confirmation Hearing

(1/22, Maaisha Osman, Inside Health Policy) ...Sen. Elizabeth Warren (D-MA) launched a blistering pre-hearing challenge to HHS secretary nominee Robert F. Kennedy Jr., blasting him with 175 questions asking him to explain his "dangerous" vaccine rhetoric, "inconsistent" positions on reproductive health, and commitment to preserving Medicare drug price negotiations under the Inflation Reduction Act (IRA)... Sub. Req’d

Medicare Negotiations Could Fuel, Not Stifle, Innovation

(1/22, Chuanzi Yue and Marisa Miraldo, Health Affairs) ...By focusing on therapeutic value, the Medicare Drug Price Negotiation Program may encourage meaningful pharmaceutical development, while discouraging practices such as "evergreening" that extend patents without adding real clinical benefits. When competition is robust, companies are incentivized to innovate, differentiating their products to maintain market share and profitability. In contrast, when competition is weak, companies may focus on evergreening or reducing R&D spending. CMS's price negotiation process should therefore focus on clinical benefits and unmet medical needs, rather than attempting to factor in imprecise measures of prior federal financial support that may reduce innovation and competition in the long run... Full

AstraZeneca Exec Stresses Calquence's Patent Life Ahead of Next Medicare Negotiations

(1/22, Nicole DeFeudis, Endpoints News) ...AstraZeneca's blood cancer drug Calquence is among the next 15 drugs subject to IRA negotiations. It's one of the company's top sellers in oncology, generating $2.5 billion in 2023. And it's "still got plenty of life left on the patent," David Fredrickson, executive VP of AstraZeneca's oncology business unit, told Endpoints News in an interview. Many of the drugs selected for the government's first round of negotiations were "at the end of their life cycle," Fredrickson said...Calquence is covered by a range of patents, some of which don't expire until 2036, according to the FDA's database of approved drugs. Other drugs on the list also have some patents extending into the 2030s, such as Teva's Austedo and Novo Nordisk's semaglutide products... Full

Vanda Loses Constitutional Fight Over FDA's Drug Talks with Competitors

(1/22, Alexis Kramer, Endpoints News) ...The opinion, published Wednesday in the US Court of Federal Claims, sheds light on the extent to which a drugmaker has a protected property interest in dissolution or other specifications for its product. The court rejected Vanda's argument that the FDA's actions amounted to an unlawful taking of property under the Fifth Amendment because the specifications at issue were generated by the agency... Full

Keren Haruvi Reelected Chair of the Association for Accessible Medicines Board of Directors

(1/22, AAM) ...The Board of Directors of the Association for Accessible Medicines has reelected as Chair for a second one-year term, Keren Haruvi, President, Sandoz North America. The Board also reconfirmed for a second term Bob Hoffman, Chief Commercial Officer of US Generics for Lupin Pharmaceuticals, Inc. as Vice Chair of the Board, and Jeff Burd, President & CEO, North America, Ajanta Pharma USA Inc. as Treasurer... Full

Better Luck Next Year: US FDA CRLs May Be Rising, But Are Not The End Of The Story

(1/22, Bridget Silverman, Pink Sheet) ...The US FDA issued 16 complete response letters for novel agents in 2024, but one of the impacted applications already has been approved and four more have been resubmitted. By the end of 2024, the FDA approved 11 of the 21 novel agents that received CRLs in 2023. CRLs roughly are split between clinical and quality topics, but substantial clinical concerns require the longest and most extensive efforts to continue development... Global Sub. Full

Missouri Bills Target Pharmacy Costs, Insurance Rules On Drug Pricing

(1/22, Rudi Keller, Missouri Independent) ...Two bills discussed Wednesday by the Senate Families, Seniors and Health Committee would expand on that legislation and take on one of the other major features of prescription sales — pharmacy benefit managers, or PBMs. State Sen. Travis Fitzwater, a Republican from Holt's Summit, wants to protect independent pharmacies from practices that favor large chain operations. His bill would require reimbursements to all pharmacies to be the same as reimbursements for pharmacies affiliated with PBMs... Full

Experts: Trump Move To Withdraw From WHO Doesn't Follow Law

(1/22, Jessica Karins, Inside Health Policy) ...President Donald Trump's decision to withdraw the United States from the World Health Organization (WHO) in one of his first executive orders may not follow legal requirements for ending membership in the international agency, according to experts, as the decision faces significant criticism from public health stakeholders... Sub. Req’d

Spain Bets On New Pharmaceutical Strategy To Boost Access And Innovation

(1/22, Francesca Bruce, Pink Sheet) ...Spain's new three-pronged strategic plan to bolster the pharmaceutical industry will also strengthen research and innovation, improve timely access to medicines and ensure strategic autonomy in the production of medicines. The plan will mean an overhaul of the current pricing and reimbursement system, including the creation of a new system for evaluating the efficiency of new. Improving the R&D infrastructure, encouraging more public-private partnerships and proposals to generate more real-world knowledge are also part of the plan... Global Sub. Full

Bulgaria Expects New Drug Production Boost from EU Pharma Package

(1/23, Antonia Kotseva and Krassen Nikolov, Euractiv) ...The European Union's revised pharmaceutical sector legislation is expected to pave the way for new production facilities in Central and Eastern European countries, according to a Bulgarian position paper sent exclusively to Euractiv. Sofia's primary objective during the negotiations of the new EU pharmaceutical legislation is to ensure that the country will have equal access to innovative therapies at prices within the limits of Bulgaria's restricted state budget... Full

Japan In 2025: Policy Give, Pricing Take Set To Continue

(1/23, Lisa Takagi, Pink Sheet) ...There is optimism around continued government investment in bioventures and startups, along with foreign firm-friendly policies designed to ease approval processes, including allowance of some English-language documents, both policies that kicked off under former prime minister Fumio Kishida. However, these will be balanced by growing uncertainty around drug reimbursement price cut policies under the country's national health insurance (NHI) scheme, including a surprise proposal for a sales tax on certain innovative medicines that has upset foreign pharma associations... Global Sub. Full

Trump's Drug Pricing Overhaul Could Reshape Korea's Biosimilar, Pharma Sectors

(1/23, Kim Dong-young, Asia News Hub) ...The policy could prove advantageous for Korean biosimilar manufacturers, whose products match the efficacy of original drugs but come at a fraction of the cost. Analysts at the Korea Health Industry Development Institute suggest that Trump's favorable stance on biosimilars and generics might help sustain or even boost U.S. demand for Korean pharmaceutical exports. However, the changes present challenges for South Korean firms focused on developing novel drugs. Lower U.S. pricing benchmarks could diminish returns on investment, potentially curbing research and development spending... Full

Indian Pharma Exudes Confidence to Sustain US Market Presence Under President Trump's Regime

(1/23, Nandita Vijayasimha, Pharmabiz.com) ...Indian pharmaceutical industry is hopeful that under the new President Donald Trump's regime Indian pharma companies can expand their presence in the US market and will continue to iron out various issues such as drug supply shortages and lower price erosion. There are only a handful of medicine manufacturing plants in the US and so dependence of India over China is imminent... Full

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