Wednesday, April 22, 2026

 

 

Teva, NeuroGen Partner on Migraine Drug in Chinese Mainland

(4/22, Zhang Chenxu, China Daily) ...Under the agreement, NeuroGen will obtain exclusive rights to commercialize AJOVY in the Chinese mainland along with exclusive licenses to related product patents and trademarks. It will also become the marketing authorization holder for the product in the mainland market, according to Teva... Sub. Req'd

 

Biopharmaceutical Company Teva to Bring Innovative Migraine Treatment to China With NeuroGen Pharma

(4/22, Xu Wei, Yicai Global) ..."Ajovy shows Teva's long-term investment and continuous innovation in the field of neurology," said Huang Diren, general manager of Teva. Ajovy is available in over 45 countries and has become the leading preventive injection treatment option for migraines in many of them, he added... Full

 

 

Top Drug Lobbyist Calls Trump's Efforts to Codify His Drug Pricing Deals 'The Wrong Policy Prescription'

(4/21, David Lim, Politico) ..."The administration deserves enormous credit for the leverage that they're applying in these bilateral discussions with other countries, the U.K. has made some commitments and, hopefully, other countries like Germany, Japan and others will follow suit," [PhRMA CEO Stephen Ubl] said at POLITICO's Health Care Summit on Tuesday. But he said congressional codification of the deals, whose details are still secret, would be a step too far... Full

 

Calley Means Criticizes PhRMA CEO Over Drug Pricing Comments

(4/21, Politico) ...[video]... Full

 

Senators Hassan, Grassley Call for Review of Big Pharma Tactic to Raise Drug Costs

(4/21, Senator Maggie Hassan) ...U.S. Senators Maggie Hassan (D-NH), and Chuck Grassley (R-IA) are calling on the Government Accountability Office to investigate pharmaceutical companies' use of "coupons," as a tactic used to steer patients away from lower-cost generics... Full

 

'Don't Be a Wimp,' Mark Cuban Tells Lawmakers Hesitant to Break Up PBMs

(4/21, Dave Muoio, Cailey Gleeson, Fierce Healthcare) ...One potential fix that he said has his whole-hearted support is the long-shot Break up Big Medicine Act..."Don't be a wimp. Seriously," Cuban said during an on-stage interview. "I've heard there's like five or six Democrats waiting to come out and support [the] senators, but they're waiting to have five or six Republicans to step up with Josh Hawley."... Full

 

Warnings Of China Taking Lead In Biopharma Future In Latest Senate Hearing

(4/21, Kenneth Rapoza, CPA) ...[Brian J. Miller, MD, an Associate Professor of Medicine at Johns Hopkins University School of Medicine], who was one of three witnesses in the hearing about the cost of making drugs, was asked what the Food and Drug Administration could do to help local pharmaceutical companies. He suggested Congress transition the FDA to focus on standardizing initial analysis of new medicines and to "serve as a counselor and guide to product developers," he said. "We are going to lose American dominance in the life sciences industry to China. This is the same industrial policy that China uses to take over other markets. Last year, 42% of new drug licensing deals came from China."... Full

 

Klomp Says CMS May Need To Tweak WISeR, As Dems, Stakeholders Oppose Model

(4/21, Sigi Ris, Inside Health Policy) ...[Medicare Director Chris Klomp] also pushed back against criticism of the model, including that expanding prior authorization in traditional Medicare via CMMI conflicts with CMS' goal of reducing the practice in Medicare Advantage plans. CMS aims to reform, not eliminate prior authorization, Klomp said. Plus, the agency is still learning from the model... Sub. Req'd

 

RFK Jr.: MFN Deals Secret, But Klomp Can Share Language To Codify TrumpRx

(4/21, Jessica Karins, Inside Health Policy) ...[Sen. Jeff Merkley (D-OR)] said the only way Congress can work on codifying the MFN agreements, as President Donald Trump and HHS officials have repeatedly asked lawmakers to do, is to have access to the terms of the agreements. "Obviously, they're not looking for the secret formulations or anything that would be proprietary, but certainly the drug pricing," he said... Sub. Req'd

 

Medicare Obesity Drug Pilot Extended After Insurer Pushback

(4/22, Phil Taylor, PharmaPhorum) ...The pilot has been extended by a year, with the federal government footing the bill for the medicines while discussions continue with the insurers about signing up for a longer-term programme, originally due to begin at the start of next year... Full

 

Hospitals Rebuff HHS's Request to Survey Drug Acquisition Costs

(4/22, Ganny Belloni, Bloomberg) ...The Centers for Medicare & Medicaid Services finalized a rule in November requiring low-income serving hospitals that receive reduced-priced drugs under the federal government's 340B drug discount program to verify the amount they paid to acquire their prescriptions. The results of the analysis, following the submission deadline of March 31, will be used to establish drug payment rates for 2027... Full

 

Editorial: Oncologists vs. the FDA and RFK Jr.

(4/22, The Wall Street Journal) ...Denying patients a life-saving medicine for inexplicable reasons is the wrong kind of change. If Dr. Makary doesn't understand that, the FDA needs a change in leadership... Sub. Req'd

 

FDA Cites Drug Manufacturers, Compounders Over Sterility Issues

(4/21, Ferdous Al-Faruque, Regulatory Focus) ...A common theme across several of the letters is that the manufacturers failed to ensure their products were made in sterile, sanitary conditions... Full

 

Spanberger Shows Political Courage by Rejecting Drug Pricing Plan That Would Have Hurt Virginians

(4/22, Larry Hogan, The Richmond Times-Dispatch) ...Gov. Spanberger's decision not to sign SB 271 in its current form shows she cares more about getting to the right answer than empty talking points. This is the right approach... Full

 

Maryland Drug Affordability Efforts Draw Praise, Concern From Local Pharmacies

(4/21, WBOC) ...For many Marylanders, the cost of medication remains a significant concern. Recent polling shows that 70 percent of residents worry about high drug prices. Meanwhile, about 30 percent say they have skipped doses, rationed medication, or left prescriptions unfilled due to cost. Catherine Kirk Robbins with the Maryland Health Care for All Coalition says those numbers highlight the need for action. "We know that drugs don't work if people can't afford them, and the board has taken real action that will bring relief to state and local government entities," Robbins said... Full

 

States Should Avoid Repeating The IRA's Price-Setting Mistakes

(4/21, Reid Porter, PhRMA Blog) ...Many states are beginning to employ more effective tools, such as requiring health insurance companies and PBMs to share at least part of their negotiated savings with patients at the pharmacy counter, as well as protecting patient assistance and insurance design fixes, to reduce patient costs today without jeopardizing access, competition or innovation. If states want to improve affordability and access, the lesson from the IRA is simple: don't repeat a policy that's already failing patients... Full

 

 

Roche Plans Global Submissions for Enspryng in Rare Autoimmune Disease

(4/21, Elizabeth S. Eaton, FirstWord PHARMA) ...The Swiss pharma said Tuesday it's teeing up global regulatory applications after the mAb met its primary endpoint in the Phase III METEOROID study in patients with myelin oligodendrocyte glycoprotein antibody-associated disease (MOGAD)... Full

 

Roche Submits Multiple Sclerosis Drug Fenebrutinib to Regulators Despite Patient Deaths

(4/22, Reuters) ...The company already shared its late-stage trial results in patients with primary progressive multiple sclerosis (PPMS), but Wednesday's data provided more details on its efficacy in relapsing multiple sclerosis (RMS). Compared with oral drug teriflunomide, which also treats RMS and is made by France's Sanofi, Roche's experimental drug more than doubles a patient's time without relapses, the company's Chief Medical Officer Levi Garraway said... Full

 

Exclusive- Merck , Rivals Eye Deal for Inhibrx Experimental Cancer Drug Tied to Keytruda, Sources Say

(4/22, Reuters) ...The San Diego-based biotech is exploring the joint spin-off of the drug, INBRX-106, and a second experimental cancer treatment, which could have a combined value of more than $9 billion if clinical trials succeed, the people said... Full

 

Sage Alumni Launch Tortugas with $106m to Advance CNS Pipeline

(4/21, Anna Bratulic, FirstWord PHARMA) ...The most advanced candidate, TRTL-107, is a D2/D3 partial agonist and 5-HT2A antagonist being tested in schizophrenia. The drug is designed with a specific binding affinity that Jonas said could give the drug a clinical edge over antipsychotics already on the market. Another of the company's pipeline candidates, TRTL-913, targets tinnitus through GABA-A receptor modulation. Both are partnered with Hansoh... Full

 

 

Amneal Pharmaceuticals to Acquire Kashiv Biosciences in Biosimilar Deal

(4/22, StreetInsider.com) ..."We are thrilled to combine Kashiv's highly complementary portfolio and capabilities with Amneal at this critical inflection point for the biosimilar market, particularly in the U.S.," said Dr. Sandeep Athalye, Chief Executive Officer at Kashiv. "With Kashiv, Amneal becomes a fully integrated global biosimilars leader at the forefront of the next wave of U.S. affordable medicines," said Chirag Patel, Co-Founder and Co-Chief Executive Officer of Amneal... Sub. Req'd

 

Apotex Receives FDA Tentative OK for Generic Ozempic

(4/21, Sandra Levy, Drug Store News) ...Developed through a strategic partnership with Orbicular Pharmaceutical Technologies, the semaglutide injection program is a result of sophisticated development capabilities, including advanced analytical characterization and deep process understanding... Full

 

Lupin Launches Generic Diabetes Drug in the US

(4/22, Devdiscourse) ...The launch follows the approval of Lupin's abbreviated new drug application by the US Food and Drug Administration (USFDA), confirming the drug's bioequivalence to Xigduo XR. Available in dosages of 5 mg/500 mg, 5 mg/1,000 mg, 10 mg/500 mg, and 10 mg/1,000 mg, the medication aims to provide effective treatment for diabetes patients across the US... Full

 

 

Merck to Partner with Google Cloud on AI Initiatives

(4/22, Reuters) ...Merck & Co said on Wednesday it will partner with Google Cloud to build up its artificial intelligence capabilities, investing as much as $1 billion with Google over a number of years to fund AI infrastructure, engineers and licensing of the tech company's Gemini Enterprise platform... Full

 

 

China's 'Landmark' Drug Pricing Guidelines Widen Biotech Profit Window: Analysts

(4/22, Julie Zhang, South China Morning Post) ...Under volume-based procurement, the government buys drugs in bulk for public hospitals, putting multinational companies under intense price and competitive pressure. The policy allows biotech companies to charge higher prices in the private market, including at private hospitals and retail pharmacies, and online... Full

 

Germany Risks Missing Out on New Drugs, AstraZeneca CEO Tells Paper

(4/21, Reuters) ..."When we can't launch some of those products, it's really a problem," he was quoted as saying by the newspaper. "It's going to be very hard for us, we're going to be attacked, but in the end we will have no choice, also because of the pressure in the U.S." Germany's coalition government last week announced a raft of measures to overhaul the statutory health insurance system to reduce a looming funding gap by 20 billion euros... Full

 

The Generics Bulletin Podcast: Green Regulations With Medicines for Europe's Adrian van den Hoven

(4/22, Urte Fultinaviciute, Generics Bulletin) ...Senior reporter Urte Fultinaviciute is joined by Adrian van den Hoven, director general of Medicines for Europe, to discuss the potential ban of all per- and polyfluoroalkyl substances or PFAS, colloquially known as forever chemicals, as well as the widely criticized Urban Wastewater Treatment Directive and its extended producer responsibility mechanisms... Global Sub. Full

 

New Guide on Opportunities in the Pharmaceutical Sector in Norway

(4/21, ANSA English) ...The new digital guide published by the Italian Embassy in Oslo, titled "The Pharmaceutical Sector in Norway," was created with the aim of providing a clear and comprehensive overview of the Norwegian pharmaceutical market, characterized by a constantly expanding market for medicines and per capita consumption that grew by 29% between 2015 and 2024... Full

 

JSS Medical College to Host Workshop on Generic Medicines, Global Challenges

(4/21, The Hindu) ...JSS Academy of Higher Education and Research (JSS AHER), Mysuru, will conduct an international workshop on 'Generic drugs: Science, technology, regulatory issues and societal dimensions in the developing world' at Sri Rajendra Auditorium, JSS Medical College, in Mysuru, on April 23 and 24... Full

 

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