Monday, June 15, 2026

 

 

Teva's Biosimilar Boom Is Just Getting Started. Is It Time to Buy This Rebounding Pharma Stock?

(6/12, Alex Carchidi, The Motley Fool) ...Teva Pharmaceutical Industries has clawed back from the brink like few drugmakers have. After a long stretch of poor performance, a company once buried under debt, patent cliffs, and litigation is now up by 97% in the last 12 months. The bull case credits its expanding biosimilars lineup, and that quickly growing segment could mean the stock has more room to run... Full

 

 

CMS Proposes Permanent Framework for Medicare Drug Price Negotiations

(6/12, Heather Landi, Fierce Pharma) ...The Centers for Medicare and Medicaid Services said a permanent framework would create "a more transparent and sustainable process for lowering drug costs for millions of Medicare beneficiaries" while providing drug manufacturers more certainty. The proposal includes policies for negotiating and renegotiating high-cost, single-source drugs beginning with initial price applicability year 2029, CMS said in a press release issued Friday... Full

 

Trump Administration Revisits Policy to Close Medicare Drug Price Negotiation Loophole

(6/12, John Wilkerson, STAT+) ...In a somewhat different approach than it considered last year, the administration is proposing to subject certain types of combination biologics to negotiation in some cases. They're trying to tie the policy to statute and program integrity. Basically, they say that if the new active ingredient allows the existing product to be administered in a different way, they're grouping the two products together... Sub. Req'd

 

Survey Shows Voters Favor Commitment To MFN Pricing Policies

(6/12, Gabrielle Wanneh, Inside Health Policy) ..."My former colleagues are right to point out that there has been a lack of transparency around how the pharmaceutical industry's Most Favored Nation agreements are structured, and lawmakers on both sides of the aisle are justified in seeking clarity on these deals," former Democratic House member Joe Cunningham, a spokesperson for PRA, told Inside Health Policy. "But what this polling makes clear is that voters do not want to keep paying some of the highest prescription drug prices in the world. Instead, they want action. It is incumbent upon lawmakers to heed that call and codify MFN immediately in a way that delivers both transparency and real savings for all Americans."... Sub. Req'd

 

Price Controls Reduce Development and Access to Vital Cures

(6/12, Eric Maus, Citizens Against Government Waste) ...Price controls in any industry, including biopharmaceuticals, do not work and inevitably lead to shortages and disrupted markets. According to a 2026 Leerink Center for Pharmacoeconomics report, government intervention like the IRA and MFN threaten the innovation of novel cures and decrease incentives for generics and biosimilars to enter the market. The report estimates that for every $140 million in branded sales the year prior to entry, there is approximately one more generic entrant... Full

 

Congress Eyes Drug Discount Changes After Legislative Stall

(6/15, Victoria Knight, Bloomberg Government) ...Under-the-radar discussion of changing 340B has stalled in Congress for years, but lawmakers may finally be ready to tackle the issue again... Sub. Req'd

 

Antitrust Mistake Enters the Drug Market

(6/12, Sam Raus, Washington Examiner) ...If lawmakers are serious about lowering prescription drug costs, they should focus on the underlying drivers of healthcare spending rather than dismantling business arrangements that often generate efficiencies. Breaking apart PBMs and pharmacies may satisfy political demands for action, but it is unlikely to make medicines more affordable... Full

 

Payer Preference Shifts Toward Unbundled, Transparent PBM Models

(6/12, Brian Nowosielski, Drug Topics) ...This shift is characterized by the rise of unbundled pharmacy benefit manager (PBM) service models, where core functions such as claims adjudication, pharmacy network management, and specialty drug management are contracted separately rather than through a single vendor... Full

 

Medicare Weight-Loss Drug Coverage Could Overwhelm Doctors

(6/15, Tina Reed, Axios) ...Next month's launch of a Medicare program providing weight-loss drugs for $50 a month is expected to unleash pent-up demand for Wegovy, Zepbound and other blockbuster treatments - and create new bottlenecks at doctors' offices... Full

 

Pentagon Cleared WuXi AppTec Once. Now It Is Being Sued for Changing Its Mind.

(6/12, Maaisha Osman, Pink Sheet) ...WuXi AppTec Co., Ltd. has sued the US Department of War to overturn its designation as a "Chinese military company" - and to force the Pentagon to spell out what evidence it must hold before placing any company on the Section 1260H list. The Chinese contract research and manufacturing giant calls its designation politically motivated, factually baseless, and legally defective... Global Sub. Full

 

BsUFA IV: Industry Questions US FDA's 'Buy One, Get One Half Off' Application Fee Proposal

(6/12, Derrick Gingery, Pink Sheet) ...Agency officials offered to eliminate multiple application fees in the biosimilar user fee structure when the program is renewed in October 2027. Instead of separate fees for applications with clinical data and without clinical data, the FDA suggested a single application fee and would charge half the fee for secondary BLAs with the same drug substance that are submitted simultaneously. The idea is intended to incentivize sponsors to submit secondary BLAs for the same drug substance at the same time, the agency said during a May 7 BsUFA IV negotiation session... Global Sub. Full

 

FDA Workshop Highlights Promise, Risks Of AI In Generic Drug Reviews

(6/12, James Jarvis, Inside Health Policy) ...Speakers discussed whether AI could be used to update the inactive ingredient database, calculate maximum daily dose values, audit applications before submission, support pharmaceutical quality assessments and monitor post-approval manufacturing changes. But they also repeatedly returned to the same concerns: whether the tools can be validated, whether outputs can be traced back to source material, how to guard against hallucinations and how much human review should be required before AI-generated information is used in regulatory decision-making... Sub. Req'd

 

Orange You Glad You Used the Right Form?

(6/15, Sara W. Koblitz, FDA Law Blog) ...There is little in the way of substantive advice in the new guidance, but it does highlight several recurring deficiencies that sponsors should watch out for... Full

 

HHS Denies Rumor Kennedy Could Leave Government In July

(6/12, Jessica Karins, Inside Health Policy) ...Robert Malone, an anti-vaccine activist who was briefly a Kennedy-appointed member of the Advisory Committee on Immunization Practices (ACIP), said on social media Friday he had heard from senior U.S. government officials Kennedy was set to leave HHS sometime in July. While Malone's views frequently come with misinformation and conspiracy theories, he is influential among some "Make America Healthy Again" supporters. He also said CMS Administrator Mehmet Oz would lead a transition team... Sub. Req'd

 

State-Run Drug Company Can't Fix a Broken Patent System

(6/12, Wayne T. Brough, R Street) ...While CalRx may help a narrow slice of the market, a state-run drug label will not fix the broader challenges that limit access to more affordable generic drugs. The problem is not a shortage of generic manufacturers, it is the fact that brand-name companies exploit the patent system through patent thickets, product hops, and lawsuits... Full

 

Cigna's Express Scripts Sues to Block Pharmacy Ownership Law in Tennessee

(6/12, Amina Niasse, Sriparna Roy, Reuters) ...Cigna's pharmacy benefits services unit Express Scripts requested on Friday that a federal court strike down a Tennessee state law that it says would restrict access to prescription medications and health care for hundreds of thousands of residents... Full

 

 

New TALVEY® (talquetamab-tgvs) plus DARZALEX FASPRO® (Daratumumab and Hyaluronidase-fihj) Data Demonstrate the Strength of a Bispecific Combination in Earlier-Line Relapsed or Refractory Multiple Myeloma

(6/15, Johnson & Johnson) ...TALVEY® plus DARZALEX FASPRO® with or without pomalidomide showed progression-free survival of up to 81% and overall survival of up to 89% at 24 months... Full

 

In Latest Twist in Zepzelca Saga, Jazz and Pharmamar Lung Cancer Drug Fails Phase 3 Test

(6/12, Angus Liu, Fierce Pharma) ...The phase 3 flop threatens Zepzelca's initial FDA go-ahead-an accelerated approval earned six years ago in previously treated SCLC based on tumor shrinkage data from a phase 2 single-arm study. Since then, what was originally meant to be the indication's confirmatory trial, a phase 3 called Atlantis, failed to show an overall survival benefit for Zepzelca and doxorubicin compared with physician's choice of chemotherapy in second-line SCLC... Full

 

The Researcher Who Didn't Want to Know

(6/15, Gina Kolata, The New York Times) ...On my second visit with Nancy Wexler at her Manhattan apartment, she had a gift for me. It was a copy of her newly published memoir, "My Life, My Science: Pursuing a Cure for Huntington's Disease." It had been signed with a stamp of her signature - she isn't able to sign it herself... Sub. Req'd

 

 

Dr. Reddy's Announces the First-to-Market Launch of Bosutinib Tablets 400mg, a Generic Equivalent of Bosulif®, in the United States

(6/13, Dr. Reddy's) ...Dr. Reddy's has collaborated with MSN Laboratories Private Limited ("MSN"), a leading pharmaceutical company in India, on this product. Dr. Reddy's holds the exclusive marketing rights for the product in the United States. MSN is responsible for the development and manufacturing of the product... Full

 

Livzon Gains Chinese Approval For Fertility Biosimilar

(6/12, Anabel Costa-Ferreira, Generics Bulletin) ...Livzon MABPharm has announced approval from China's National Medical Products Administration for its recombinant human follitropin alfa solution for injection...Demand for the product is expected to grow as the incidence of reproductive disorders, including infertility in China has increased each year, with a widening younger patient demographic... Global Sub. Full

 

Celltrion Expands Vietnam Portfolio With Two Oncology Biosimilars

(6/15, Lee Han-soo, Korea Biomedical Review) ...Celltrion has launched two oncology biosimilars in Vietnam, expanding its presence in one of Southeast Asia's fastest-growing pharmaceutical markets. The company said Monday that it began commercializing Truxima (rituximab), a treatment for hematologic malignancies, and Vegzelma (bevacizumab), indicated for several cancers, including metastatic colorectal cancer and breast cancer, in Vietnam last Tuesday... Full

 

 

Johnson & Johnson CEO Joaquin Duato on Fighting Cancer, AI and Medical Innovation

(6/15, Wall Street Journal) ...On this Leaders episode, recorded at the 2026 WSJ CEO Council Summit in London, Johnson & Johnson Chairman and CEO Joaquin Duato joins WSJ Leadership Institute President Alan Murray to discuss the company's focus on tackling some of healthcare's most complex challenges, breakthroughs in cancer treatment, the future of longevity, and the role AI is playing in accelerating medical innovation... Sub. Req'd

 

GSK Took Advantage of ASCO Dip to Get Discount on Nuvalent

(6/12, Max Gelman, Endpoints News) ...Laura Prendergast, a biotech analyst who follows Nuvalent for Stifel, said she believed the deal price was fair. The biggest question for Nuvalent - and now GSK - is how long it will be before the buyout starts to pay off. Nuvalent's most promising drug, an ALK inhibitor called neladalkib, likely won't start pulling in significant revenue until 2029 or 2030 at the earliest... Sub. Req'd

 

Abridge Partners with Eli Lilly, Nvidia as AI Scribe Eyes Expansion

(6/12, Emily Olsen, Healthcare DIVE) ...The AI company is working with Nvidia to create a foundation model, or a base model built on large amounts of data that can be used for a number of general tasks, to be geared toward clinical conversations. Additionally, Lilly is making a strategic investment in Abridge "to support evidence-based care and research access at all the moments of care," CEO Shiv Rao said during a keynote presentation. The size of the investment was not disclosed... Full

 

Drugmakers Race to Find a Place in the Next Wave of Obesity Drugs

(6/13, Angeliza Peebles, CNBC) ...Lilly and rival Novo Nordisk showcased new GLP-1 pills they each introduced earlier this year. Both companies made the case that oral options are bringing more people into the market for weight loss drugs, with Novo touting that prescriptions of its Wegovy pill reached more than 3 million just five months into the launch... Full

 

Cheaper Generic Ozempic Is Here. Here's What We've Learned Since These Drugs Exploded Onto the Scene

(6/14, Kevin Jiang, Toronto Star) ...It's relatively easy to obtain semaglutide in Canada. Star reporter Morgan Bocknek detailed how she attained a prescription with ease, even though she shouldn't have qualified for one, through private telehealth companies...Now, with far cheaper generics available, experts warn against the rise of over-prescription and misuse... Full

 

Primary Care Doctors Raise Alarm as Telehealth Companies Get Involved in Obesity Drugs

(6/14, Sydney Lupkin, NPR) ...Telehealth companies such as Vida Health and its rivals offer lifestyle support so people taking drugs like Wegovy and Zepbound can have the most success on the drugs. But the companies often have another job: limiting obesity drug costs for employers... Full

 

A Practical Guide for Pharmacy Drug Shortages

(6/13, Kimberly Rath, Drug Topics) ...Although no pharmacy can prevent shortages at the manufacturer or national supply level, the good news is that meaningful resilience does not require a large budget or an enterprise procurement team. It requires the right systems, the right supplier relationships, and a shift from reactive to proactive thinking... Full

 

U.S. FDA Classifies Aurobindo Pharma Arm Eugia's Formulation Plant as OAI

(6/13, N. Ravi Kumar, The Hindu) ...Aurobindo Pharma subsidiary Eugia Pharma Specialities' formulation manufacturing facility near Hyderabad has been classified by the U.S. Food and Drug Administration (U.S. FDA) as "official action indicated" (OAI)...This is the second plant of the Aurobindo subsidiary to be classified as OAI. The U.S. FDA had also determined Eugia Pharma Specialities' formulation manufacturing facility in Kolthur village of Ranga Reddy district, near Hyderabad, to be OAI in May... Full

 

 

Drugmakers Will Not Be Exempt From Cost Cuts, Says German Health Minister

(6/12, Reuters) ..."Every sector must play its part in this reform," Health Minister Nina Warken was quoted as saying by the Funke newspaper group on Friday... Full

 

Generics Pricing Pact Gives Canada Two More Years

(6/15, Dean Rudge, Generics Bulletin) ...Canada's public drug-plan negotiator and the generics industry have agreed to keep their national generic-drug pricing deal in place until 2028. Under the extension, the pan-Canadian Pharmaceutical Alliance and the Canadian Generic Pharmaceutical Association will maintain their national pricing initiative for generic medicines for a further two years, preserving a framework intended to deliver savings and price predictability for medicines reimbursed by Canadian public drug plans... Global Sub. Full

 

The 'Special Sauce' Needed To Achieve Quality In Clinical Trials

(6/12, Vibha Sharma, Pink Sheet) ...The clinical trial industry has a compliance culture problem, and the International Council for Harmonisation's new good clinical practice (GCP) guideline alone will not fix it. That was the frank message from drug regulators in the US, the UK and Canada at a recent joint symposium, where they warned that the ICH E6(R3) guideline demands a "fundamental shift" away from the "checklist mentality" that has long dominated trial conduct - starting at the leadership level... Global Sub. Full

 

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