Thursday, April 16, 2026

 

 

Teva Launches New Online Schizophrenia Community Project

(4/15, Ben Adams, Fierce Pharma) ...Just two months after the FDA accepted for review Teva's long-acting version of a decades-old schizophrenia drug, the Israeli pharma is launching a community project to help people with the disorder and their carers. The idea is to "help people learn from others, feel less alone and address real-life needs with resources that are useful, understandable and actionable," according to an April 15 release. There are several tools attached to the project, including symptom tracking via printable worksheets, as well as information about local and national community events "to connect people with schizophrenia and their care partners to their community," Teva said... Full

 

Teva Launches "Home Ground" Online Resource for People Living with Schizophrenia and Their Care Partners

(4/15, PharmaLive.com) ..."Schizophrenia care doesn't end with diagnosis and a prescription. The day-to-day realities, including isolation, can be very challenging and addressing these barriers is important for the recovery journey," said Dan Laitman, a Home Ground Ambassador and community advocate living with schizophrenia. "As someone who has firsthand experience with the power of holistic care, I see Home Ground Schizophrenia Community as an essential resource that brings peer perspectives and practical support together in one place, giving individuals and care partners a true home for support alongside their clinical care."... Full

 

Court Keeps Core Copaxone Claims Alive Against Teva

(4/15, Dean Rudge, Generics Bulletin) ...In an opinion adopting a special master's detailed report and recommendation, the US District Court for the District of New Jersey has partially granted Teva's motion to dismiss Mylan's complaint... Global Sub. Full

 

Still Looking for the Next Warren Buffett? We Found 'Him.'

(4/16, Andy Serwer, Barron's) ...Let's start with investing. Lots of good choices here, such as Ken Griffin of Citadel, Tiger Cubs -- as Julian Roberston's protégés are called -- like Lee Ainslie of Maverick and Chase Coleman of Tiger Global, Cliff Asness of AQR Capital Management, and Li Lu of Himalaya Capital, but to me Stan Druckenmiller of Duquesne stands out... As of Dec. 31, Druckenmiller maintained big holdings in healthcare companies Natera, Insmed, and Teva Pharmaceutical Industries, as well as Amazon.com, and a new, bigger stake in the State Street Financial Select Sector SPDR exchange-traded fund... Full

 

300,000 Cartons of Blood Pressure Medicine Recalled Nationwide for 'Unapproved' Formulation

(4/15, Kristine Gasbarre Qaderi, The Healthy) ...The report reveals that the recall was initiated on March 19, 2026, then further classified as Class II by the FDA on April 13, 2026. This means use of the products "may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote." The use of an unapproved ingredient is a violation of federal manufacturing standards. The affected products, made by Actavis Laboratories for Teva Pharmaceuticals, are three separate dosages in milligrams... Full

 

 

Drugmakers Raised Prices on Hundreds of Drugs Despite Trump Deals, Senate Democrats Report Finds

(4/16, Berkeley Lovelace Jr., NBC News) ...The report — released Thursday by Sen. Bernie Sanders, I-Vt., the ranking member on the Senate Health, Education, Labor and Pensions Committee, ahead of a hearing focused on drug prices — found that companies that signed drug pricing deals with Trump have raised the cost of hundreds of medications and launched new ones at an average price of $353,000 a year... Full

 

Cassidy Touts Vague Affordability Plan To Expand TrumpRx, Rein In PBMs & Push Price Transparency

(4/15, Gabrielle Wanneh, Inside Health Policy) ...[Senate health committee Chair Bill Cassidy's] new Money and Value for Patients (MVP) agenda builds off previous actions by the senator to crack down on the impact pharmacy benefit managers have on drug prices and to give money directly to Americans so they can control their own care. Measures from the health committee's PBM Reform Act were included in the Consolidated Appropriations Act enacted in February this year... Sub. Req'd

 

CSRxP Encourages Help Committee to Build Momentum Behind Bipartisan Solutions to Lower Prescription Drug Prices by Fostering Greater Competition

(4/15, CSRxP) ..."Big Pharma's egregious pricing practices and anti-competitive tactics are driving health care inflation and blocking more affordable alternatives, like generics and biosimilars, from reaching American patients and lowering prices in the marketplace," said CSRxP executive director Lauren Aronson. "Big Pharma opposes market-based solutions that would lower prescription drug prices by falsely claiming egregious prices and extended monopolies are justified by investments in innovation, despite routinely spending more on marketing than research and development (R&D) and numerous studies debunking any connection between prices set by brand name manufacturers and clinical value for patients or investments in R&D."... Full

 

Drug Pricing Plan Risks Innovation and Patients

(4/15, John Stanford, RealClearHealth) ...Risk-taking has made the United States the engine of global medical progress. Preserving that edge means protecting the incentives that reward innovation -- so we develop and deliver the next generation of treatments here first, rather than ceding that advantage to rivals like China... Full

 

Congress Can Finally Stop Big Pharma's Patent Abuse

(4/15, Sean Tu, DC Journal) ...American patients have been paying the price for Big Pharma's longstanding abuse of the patent system. Fortunately, Congress is finally taking meaningful steps to address a problem that has been overlooked for far too long. The Eliminating Thickets to Increase Competition (ETHIC) Act is the most serious effort yet to rein in abusive patent practices that delay access to affordable medicines... Full

 

PCMA Calls on DOL to Protect Competition in the PBM Market, Rescind Duplicative Proposed Rule

(4/15, PCMA) ...PCMA called on DOL to rescind the proposed rule because it is unnecessary and risks degrading a competitive and effective PBM industry. Specifically:...The proposal is blatantly redundant of the recently passed PBM reform legislation signed into law by President Trump,...The proposal offers nearly no additional meaningful transparency for employers, and...The proposal threatens to reduce competition in the PBM market... Full

 

FDA To Congress: Pass Patent, Biosimilar, Combo Product Reforms

(4/15, Gabrielle Wanneh, Inside Health Policy) ...The first proposed reform would clarify that if a brand drug company wants to sue for patent infringement against upcoming generic competition and is seeking a 30-month stay of approval until the matter is settled, patent information for the brand drug must have been submitted prior to the submission of the generic drug's application to FDA... Sub. Req'd

 

What Non-Pricing Factors Are Impacting Biosimilar Decision Making

(4/16, Mike Hollan, Thomas Newcomer, PharmExec.com) ...Pharmaceutical Executive spoke with Thomas Newcomer, SVP and head of US commercial at Samsung Bioepis about the biosimilar market in the United States...According to Newcomer, there are positive movements in areas like oncology. However, there is still a biosimilar void in the US that he says should be addressed... Full

 

CLEAR Labels Act Could Help FDA Target Inspections, Former FDA Officials Say

(4/15, James Jarvis, Inside Health Policy) ...The CLEAR LABELS Act would require manufacturers to identify the original source of finished drugs and their active pharmaceutical ingredients (APIs) on labeling or through a scannable digital platform. The sponsors have framed the proposal as an early step in a broader effort to reduce U.S. reliance on foreign drug manufacturing -- particularly in China and India -- which they have characterized as both a supply chain vulnerability and a national security risk... Sub. Req'd

 

Former FDA Cancer Chief Pazdur Warns of The Political 'Breach' Of Review Teams

(4/15, Zachary Brennan, Endpoints News) ...In an interview with Endpoints News, [Richard Pazdur] pointed to several issues with FDA Commissioner Marty Makary's priorities and specifically highlighted the unprecedented political interference in the FDA's drug reviews... Sub. Req'd

 

FDA Stakeholders Hope Next CBER Head Will Rebuild Morale, Restore Staff Losses

(4/15, Jessica Karins, Inside Health Policy) ...Stakeholders say it's important to tap a new biologics chief who can rebuild morale and help stabilize staff losses after layoffs and other departures have decreased the agency's capacity... Sub. Req'd

 

HHS Brings on an Affordability Czar

(4/16, Caitlin Owens, Axios) ...HHS has appointed Casey Mulligan as chief economist and chief regulatory officer. He'll advise Health Secretary Robert F. Kennedy Jr. and other agency leaders on affordability issues... Full

 

Big Health Industry Group Sues WA Over New Drug-Pricing Law

(4/15, Elise Takahama, The Seattle Times) ...This most recent lawsuit is brought by the Pharmaceutical Research and Manufacturers of America, or PhRMA, a massive drug industry trade group. The new state law is meant to protect a decades-old federal program that pushes drugmakers to provide discounted medications to certain hospitals that care for low-income and rural patients. As in the other pending lawsuits, PhRMA says the state shouldn't be allowed to make revisions to a federal program, and accuses the new law of being "entirely parasitic" to the nationwide initiative... Full

 

Maryland Bid to Cap Jardiance Cost Spurs Pushback From Skeptics

(4/15, Ian Lopez, Bloomberg Government) ...Under the Maryland board's plan, the price for a 30-day supply of Jardiance would be limited to $204. The drug's list price is $350 for a month's supply. Maryland's PDAB estimated its effort would save around $320,000 a year for state and local governments. The decision to set an UPL on Jardiance will be finalized following a public comment period and a subsequent vote... Sub. Req'd

 

 

BMS Makes a Beeline, Bringing 5 Assets to Biotech's $300M Precision Immunology Debut

(4/15, Tristan Manalac, BioSpace) ...In July 2025, Bristol Myers Squibb announced that it was spinning out a startup with help from leading life sciences investment firm Bain Capital. BMS would fill its initial pipeline with five assets while Bain would help build buzz with $300 million in opening funds. The spinout has stayed in stealth since then but took off Wednesday with the name Beeline Medicines and a mission to advance precision therapies for autoimmune and inflammatory conditions, according to a company release... Full

 

Health Canada Approves 1st Needle-Free Epinephrine Treatment for Severe Allergic Reactions

(4/15, CBC News) ...ALK Canada, which purchased the rights to distribute the drug, says the two-milligram treatment has been approved for adults and pediatric patients who weigh at least 30 kilograms — roughly 66 lbs. It says the spray could be on the market as soon as this summer... Full

 

 

Samsung Win Protects Early Foothold In US Ustekinumab Market

(4/15, Dean Rudge, Generics Bulletin) ...The appellate ruling, handed down April 14, 2026, allows Samsung to continue supplying its ustekinumab biosimilar SB17, marketed as Pyzchiva, under Quallent's private label while an underlying contract dispute proceeds to trial... Global Sub. Full

 

Mankind And Amneal Launch US Lumigan Generics Despite Valid Patent

(4/15, Urte Fultinaviciute, Generics Bulletin) ...Mankind Pharma and Amneal have launched their respective generic rivals to AbbVie's Lumigan (bimatoprost ophthalmic solution 0.01%), an intraocular pressure treatment for glaucoma patients, in the US... Global Sub. Full

 

Mabwell Establishes a Licensing and Commercialization Agreement for Denosumab Biosimilars in Malaysian Market

(4/16, Mabwell) ...Under the agreement, the partner is responsible for the registration and commercialization of the products in Malaysia, while Mabwell is responsible for the development, production and commercial supply for the products... Full

 

7 Indian Firms in Race, Experts Eye Cheaper Keytruda Version in 2 Years

(4/16, Anonna Dutt, The Indian Express) ..."We have seen this with other immunotherapies. The entry of biosimilars leads to a significant drop in prices, sometimes by as much as 70%. This is the simplest way to make cancer drugs more affordable and accessible. In the long run, however, India needs to invest in developing its own therapies," said Dr Tarun Durga, associate director of medical oncology, Medanta-Noida... Full

 

 

Astellas Manufacturing Chief Views Reliable Supply, Bridging Research as His Production 'North Star'

(4/15, Fraiser Kansteiner, Fierce Pharma) ..."Astellas manufacturing has tremendous strengths in multiple modalities as well as a strong focus on service to patients," [Astellas' chief manufacturing officer, Rao Mantri, Ph.D.,] said during a recent meeting with Fierce at the American Biomanufacturing Summit in San Francisco. "So, when I started, it was about—how do we actually make the manufacturing organization as a strategic enabler to connect research innovation to access to patients even more." He described that ambition under his leadership as Astellas' manufacturing "north star," alongside always ensuring a reliable supply of its medicines... Full

 

Sun Pharma, Grünenthal Are Said to Vie for US-Listed Organon

(4/16, Baiju Kalesh, Saikat Das, Eyk Henning, Vinivy Chan, Bloomberg) ...India's biggest pharmaceutical firm and closely held Grünenthal are working with advisers on potential binding bids for Organon that they may submit in the coming weeks, the people said, asking not to be identified discussing private information... Full

 

India's Hetero Targets Annual Sales of 1.5 Million Semaglutide Pens in Global Rollout

(4/16, Rishika Sadam, Reuters) ...Hetero plans to launch the drug in India in April, focusing on building market share overseas to begin with, Managing Director Vamsi Krishna Bandi told Reuters in March... Full

 

Celltrion Gains Ground in Europe as Prescriptions Rise Across Portfolio

(4/16, Lee Han-soo, Korea Biomed) ...Celltrion said Thursday its oncology and autoimmune treatments are gaining traction across major European markets, driven by tender wins and rising prescription volumes... Full

 

Takeda Continues to Prune Partnerships, Cuts Ties with mRNA-Targeting Veritas In Silico

(4/15, Tristan Manalac, BioSpace) ...Takeda is ending its engagement with Veritas In Silico, continuing a recent pattern of the Japanese pharma trimming its roster of collaborators... Full

 

China to Drive a Weight-Loss Drug Price War

(4/15, June Yoon, Financial Times) ...But the biggest threat to western pharma lies in manufacturing. Many Chinese drugmakers control the entire supply chain, unlike western peers that often outsource the production of raw ingredients or specialised components such as injection pens to third-party contractors... Sub. Req'd

 

Was Big Pharma's 'Unusually Aggressive' M&A Spree to Blame for March IPO Drought?

(4/15, James Waldron, Fierce Biotech) ...According to Pitchbook data shared with Fierce, global biotech and pharma IPOs in February generated a combined exit value of $5.57 billion—including $4.7 billion for U.S.-based companies alone—which far exceeded any month in the previous year. They included Aktis Oncology's $318 million offering and Belgium-based Agomab Therapeutics' $200 million Nasdaq listing... Full

 

Novartis CEO Vas Narasimhan Joins Anthropic's Board as Biopharma's Ties to AI Deepen

(4/15, Angus Liu, Fierce Pharma) ..."Getting powerful new technology to people safely and at scale is what we think about every day at Anthropic," Daniela Amodei, co-founder and president of Anthropic, said in Tuesday's statement. "Vas has been doing exactly that for years, and I'm grateful he's joining us." By tapping Narasimhan, the Claude maker and self-dubbed "AI safety and research company" is inching closer toward the world of biotech innovation while navigating the ethical boundaries that are also key to medicine... Full

 

 

Iran War: India's Supply Chain Shocks, Contract Stress And Spillover Risks

(4/16, Anju Ghangurde, Pink Sheet) ...Industry experts told the Pink Sheet that the solvents such as ethanol, isopropyl alcohol (IPA), acetone, acetonitrile, THF, DMF/DMAc and toluene have seen estimated price jumps ranging from 15% to 40% with factors such as energy inflation, refinery shutdowns, petrochemical feedstock costs, and LNG scarcity contributing to the surge... Global Sub. Full

 

New EU Market Exclusivity Rules Set 'High Threshold,' Lawyer Says

(4/15, Eliza Slawther, Pink Sheet) ...The final draft version of the pharma reform package, which comprises a new directive and regulation for governing pharmaceutical products in the EU, was published last month. The new package will see new medicines offered a standard baseline RDP period of eight years, which is the same amount of time as is on offer under the current legislation, but the baseline period of MP will reduce from two years to one... Global Sub. Full

 

Drug Makers Warn of NHS Shortages Within Weeks

(4/15, Hannah Boland, The Telegraph) ...Medicines UK, which represents companies that make 85pc of all NHS prescriptions, said it was "increasingly concerned that some chemicals and solvents used to manufacture active pharmaceutical ingredients are now in very short supply". It said this would probably result in "significant pressure for the NHS as early as June", potentially threatening Britain's ability to fulfil patients' prescriptions or forcing up costs for the health service to source those medicines... Full

 

France's Gemme Becomes ALMA

(4/15, Dave Wallace, Generics Bulletin) ...Describing itself as "the new association for an equitable healthcare system," ALMA said its new identity was "not simply a name change" but represents "a new ambition" to be "the association that brings simple and effective solutions to ensure the sustainability of our healthcare system."... Global Sub. Full

 

Indian Pharma Bets Big on Integrated Quality Ecosystems to Boost Audit Readiness and Operational Resilience

(4/15, Nandita Vijayasimha, PharmaBiz) ...As the industry expands its global footprint, the expectations surrounding quality and compliance have grown significantly. A quality lapse today does not remain confined to a single facility or geography. It travels across supply chains, regulators, and healthcare systems. In an interconnected pharmaceutical ecosystem, even isolated compliance failures can influence global trust in Indian exports, said [Duraisamy Rajan Palani, founder and CEO of Archimedis Digital]... Full

 

Worrisome Bill Could Worsen Brazil's HTA Landscape, Say Critics

(4/15, Francesca Bruce, Pink Sheet) ...Bill 4741/2024 would update law 9.961, published in January 2000, to expand the remit of the ANS, making it responsible for public and private sector HTAs and for developing clinical protocols and therapeutic guidelines. CONITEC was established in 2011 to make recommendations on which products should be funded by the SUS... Global Sub. Full

 

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