Wednesday, June 17, 2026

 

 

Medincell Reports FY 2025-26 Annual Results

(6/16, Medincell) ...Olanzapine LAI advancing into regulatory review ahead of its expected U.S. launch in Q4 2026 by Teva..."FY 2025-26 reflects an important transition phase for Medincell. Building on UZEDY's strong performance and the expected commercial launch of Olanzapine LAI by our partner Teva later this year, we are advancing the next phase of our 'Shift to Growth' strategy... Full

 

US Progesterone Supplies Tighten as Menopause Treatment Demand Grows

(6/17, Mrinalika Roy, Sriparna Roy, Reuters) ...A spokesperson for CVS Health, one of the nation's largest pharmacy chains, said manufacturers have been unable to provide sufficient HRT supplies for several months. According to an FDA database, nine companies manufacture oral progesterone, including Teva and Dr. Reddy's. Teva did not respond to a request for comment, while Dr. Reddy's said the product has not been part of its U.S. portfolio since 2022 and the company does not manufacture or market it. The FDA does not list progesterone as being in shortage... Full

 

Roche Could Emerge as Winner in New Class of Autoimmune Drugs -- Market Talk

(6/16, Dow Jones Newswires) ...Roche is expected to become the market leader thanks to afimkibart, they add. Duvakitug--which is being developed by France's Sanofi and Israel's Teva--might have a convenience advantage, but is forecast to take the No. 3 spot, Bernstein says... Sub. Req'd

 

 

Johnson & Johnson CEO Credits Trump Tax Policy for $55B US Investment Push, Including $1B In Florida

(6/16, Taylor Penley, FOX Business) ..."We have the best talent, we have the best investment environment and, very importantly, we have now the tax policy enacted with this administration that has enabled us to be competitive," CEO Joaquin Duato said on FOX Business' "Mornings with Maria" on Tuesday...Duato told "Mornings With Maria" that the company's goal is to manufacture all its medicines, medical technologies and more in the U.S., touting the move as a "show of confidence in American manufacturing."... Full

 

Senate Panel to Mark Up Biosimilar Bill

(6/17, Victoria Knight, Bloomberg) ...Pharmacists could more easily swap out brand-name biological drugs for cheaper, similar versions under legislation the Senate HELP Committee could send to the floor today. S. 1954 is part of a trio of bipartisan bills related to drug pricing the committee will consider as they mark up a total of eight bills. The legislation, which also has a House version (H.R. 5526), would automatically deem a biosimilar as "interchangeable," to the biologic, which means you don't need a provider's approval to switch it out... Full

 

Conservative Group Slams Drug Patent Bill Ahead Of HELP Markup

(6/16, Gabrielle Wanneh, Inside Health Policy) ...As the Senate health committee prepares to mark up a package of bills Wednesday (June 17) aimed at promoting competition from generic drugs and biosimilars by streamlining approval requirements and reducing delays, a conservative advocacy group is urging lawmakers to reject one proposal it calls "a solution in search of a problem," arguing it would add new regulatory burdens without lowering prescription drug prices... Sub. Req'd

 

CSRxP Encourages Help Committee to Advance Bipartisan, Market-Based Solutions to Lower Drug Prices by Fostering Greater Competition

(6/16, CSRxP) ..."CSRxP encourages HELP Committee lawmakers to see through Big Pharma's debunked innovation rhetoric, which the industry routinely wields to deflect blame for high prices, and instead advance bipartisan, market-based solutions to effectively lower drug prices for consumers, including the Biosimilar Red Tape Elimination Act, the Medication Affordability and Patent Integrity Act and the Ensuring Timely Access to Generics Act."... Full

 

The Wrong Prescription for Drug Affordability

(6/16, Merrill Matthews, The Hill) ...It would also enable generic drug companies to overturn pharmaceutical patents in court by alleging that brand-name manufacturers failed to fully comply with the new requirements...The bill's supporters assert that pharmaceutical companies routinely exploit gaps in the patent system to unfairly delay the arrival of cheap generic competitors... Full

 

The Drug Pricing Machine and Why Patients Keep Paying More

(6/16, Matthew Edwards, International Business Times) ...Pharmaceutical manufacturers deserve scrutiny for the high prices many Americans pay for prescription drugs, but they are only part of the story. Between drugmakers and patients stand pharmacy benefit managers, or PBMs, some of the most powerful and least understood players in healthcare, with growing influence over which drugs are covered, which companies succeed, and how billions of dollars flow through the prescription drug market... Full

 

When Congress Tries to Overrule Biology

(6/16, Peter J. Pitts, RealClear Health) ...The biosimilar marketplace is growing. Competition is increasing. Confidence is expanding. The system is not perfect, but it is working. Congress should focus its attention on the actual barriers to competition and affordability. It should leave the scientific determinations to the scientists. Because biology has not changed. And Congress has not discovered a way to legislate around it... Full

 

CMS Kick Starts Plans For Carrying Out Part D PBM Reform With RFI

(6/16, Gabrielle Wanneh, Inside Health Policy) ...The request for information (RFI) posted Tuesday (June 17) shows CMS is specifically interested in information it can use to determine how to ensure the compensation PBMs receive based on Part D drug utilization is connected only to bona fide service fees, and how to collect the data PBMs are now required to provide plan sponsors and HHS annually... Sub. Req'd

 

Express Scripts, PCMA Sue to Block Tennesee Law Breaking up PBMs and Pharmacies

(6/16, Rebecca Pifer Parduhn, BioPharma Dive) ..."This law is both harmful and unconstitutional, and we are confident the Court will see it that way," PCMA CEO and President David Marin said. The PCMA filed its lawsuit on Monday... Full

 

FDA Staff Scrutinizes Evidence Supporting Moderna's Flu Vaccine

(6/16, Delilah Alvarado, BioPharma DIVE) ...Documents filed on Tuesday summarize the position of staff scientists and provide a window into how the agency views the data Moderna has compiled to date. They show that reviewers found no "major deficiencies" with the vaccine, but unearthed gaps in evidence that leave unclear how well it works, particularly in the elderly... Full

 

Expert: FDA's Real-Time Release of CRLs May Violate Law, Hinder Discussion With Sponsors

(6/16, Joanne S. Eglovitch, Regulatory Focus) ...The US [FDA's] publication of complete response letters (CRLs) for unapproved drugs violates the agency's own regulations and the Administrative Procedure Act, asserted Eva Temkin, an attorney with Arnold & Porter who spoke at the DIA Global Annual Meeting on Monday. A recent citizen petition filed by law firm Covington & Burling also questions the FDA's authority to issue CRLs before applications have been approved and without providing the sponsors of those applications an opportunity to engage in the redaction process... Full

 

Relationships, Not Politics, Help Biopharma Sponsors Ride Out FDA Leadership Churn

(6/16, Sue Sutter, Pink Sheet) ...Biopharma companies that built and maintained relationships with the US [FDA's] scientific review staff are better positioned to weather the agency's leadership changes than those that tried to leverage political connections, former agency officials said... Global Sub. Full

 

Pharma's US FDA Takeover? Ex-CDER Director Wonders About Changes

(6/16, Michael McCaughan, Pink Sheet) ...Former Acting CDER Director Tracy Beth Høeg disputed the narratives about the recent FDA management changes during a podcast appearance and warned of pharmaceutical industry influence at the agency... Global Sub. Full

 

Vermont Will Join Multi-State Prescription Drug Pricing Program

(6/16, Lola Duffort, Vermont Public) ...The program, called ArrayRx, will be housed within the office of State Treasurer Mike Pieciak, who pitched the idea to lawmakers. Five states already belong to the drug pricing consortium, including Connecticut, which has reported average savings upwards of $200 a month for participants... Full

 

PhRMA Talks up the Power of 'Medicines First' in New Campaign

(6/16, Ben Adams, Fierce Pharma) ...As part of its "American Cures" campaign, launched in February, PhRMA is now running a series of new ads called "Medicines First," with perhaps a nod to the current U.S. administration's "America First" slogan... Full

 

 

Israel Moves to Reignite University Innovation Engine

(6/17, Sophie Shulman, CTech) ...Fewer startups are being born out of academia, and Israel's Ministry of Finance is attempting to revive the sector through a comprehensive reform. The commercialization of academic research has produced some of Israel's most notable success stories, including Mobileye, which emerged from the Hebrew University of Jerusalem, and Teva's blockbuster multiple sclerosis drug, Copaxone, which originated at the Weizmann Institute of Science... Full

 

Heading 'Down Under:' The Jerusalem Post Announces Sydney Summit

(6/17, The Jerusalem Post) ...The opportunity is especially timely as the Australia-Israel business relationship continues to expand. In recent years, trade between the two countries reached approximately US$1 billion, with Israeli exports accounting for nearly three-quarters of that total. Israeli companies such as Check Point, CyberArk, BioCatch, Teva, and Strauss have already demonstrated the potential for Israeli innovation to succeed in the Australian market... Full

 

 

UniQure Resolves Huntington's Dispute, Will File for US Approval

(6/17, Robert Langreth, Bloomberg) ...UniQure recently met with the Food and Drug Administration and was told an analysis of its three years of data from its existing trial would be acceptable for a filing for expedited approval, it said in a statement. The company plans to submit an application in the third quarter of this year...The FDA will consider allowing the company to compare the therapy to the current standard of care, rather than requiring the sham brain surgery that the FDA had previously demanded... Full

 

A New Westlake-Backed Biotech Takes Aim at Migraines

(6/17, Jacob Bell, BioPharma DIVE) ...Vedana wants to fill this treatment gap with antibody drugs aimed at another nervous system protein, "PACAP," which appears to drive migraines in a similar but distinct way from CGRPs. It's not alone in that pursuit... Full

 

Migraine Biotech Makes its Debut with $46m to Advance Preclinical Pipeline

(6/17, Ayisha Sharma, Endpoints News) ...Available treatments for migraine typically only reduce attack frequencies by around half. "We want to be known as the migraine company," Vedana CEO Anurag Agarwal told Endpoints News in an interview... Sub. Req'd

 

 

Sandoz Prepares for Biosimilar 'Golden Decade' with New Development Centre in Slovenia

(6/17, Catherine Eckford, European Pharmaceutical Review) ...The 10,000m², end-to-end facility will strengthen Sandoz's in-house biosimilar capabilities, supported by advanced analytics and data science. It forms part of the firm's investment of more than $1.1 billion in Slovenia. Opening of the new centre will help Sandoz capitalise on the opportunity available in the upcoming 'golden decade' for biosimilars, the company affirmed... Full

 

Egg-Based Biologics Platform Wins $23M Investor Backing

(6/16, Dean Rudge, Generics Bulletin) ...Neion Bio has raised an oversubscribed $23m Series A financing round to advance its egg-based biologics manufacturing platform and grow a broad pipeline that includes biosimilars, alongside innovative medicines, critical reagents and animal health... Global Sub. Full

 

Biosimilar Switching Maintained Disease Control in People With Ankylosing Spondylitis

(6/16, Skylar Jeremias, The Center for Biosimilars) ...Researchers from Yunnan University of Chinese Medicine conducted the review in response to a recognized evidence gap: although biosimilar switching guidance had been developed for rheumatoid arthritis, ankylosing spondylitis-specific switching data-most of which emerged after 2018-had not been systematically synthesized... Full

 

 

Apotex Public Listing Key Step in Renewed Canada-Americas Focus, CEO Says

(6/16, Chris Hannay, The Globe and Mail) ...Apotex Health Corp.'s public listing was a crucial step in the company's plans to renew its focus on Canada and the Americas, chief executive officer Jeff Watson says..."The thesis was to kind of double down on the Canadian roots, build up the Canadian business further in the next phase, but ultimately lead the company to become a Canadian publicly listed company."... Sub. Req'd

 

UCB Completes Acquisition of Candid Therapeutics, Strengthening next Generation Immunology Pipeline

(6/17, UCB) ...The acquisition strengthens UCB's position as an innovator in immunology and expands its capabilities in next-generation biologics aimed at achieving immune reset. It brings cizutamig, Candid's lead investigational asset, into UCB's pipeline. Cizutamig is a bispecific antibody targeting B-cell maturation antigen (BCMA) on plasma cells and CD3 on T-cells, designed to enable T-cell-mediated depletion of pathogenic B-cell populations. The asset is currently being evaluated in multiple Phase 1 clinical studies across a range of autoimmune diseases... Full

 

Eli Lilly's M&A Spree Continues with Acquisition of Non-Opioid Pain Drugmaker 4E

(6/16, Angus Liu, Fierce Biotech) ...In its latest deal, Lilly has acquired neuroscience startup 4E Therapeutics for an undisclosed amount, the Austin, Texas-based biotech said Tuesday. The deal gives Lilly a pipeline of early-stage, non-opioid therapeutics for various pain management indications, including neuropathic pain, migraine and acute pain, according to 4E's pipeline webpage, which has not been updated since 2023... Full

 

Lupin Manufacturing Solutions Targets Long-Term Growth as New CDMO With Pharma Roots

(6/16, Greg Slabodkin, Pharma Maufacturing) ..."The service we are offering is different," [CEO Abdelaziz] Toumi told Pharma Manufacturing. "We are switching from a product to a service organization. 2025 was a pivotal year by recruiting senior leadership that is complete now with veterans in the CDMO industry."... Full

 

How Biogen Is Transforming its Pipeline with a VC Mindset and an 'Entrepreneurial Spirit'

(6/16, Will Maddox, Fierce Biotech) ...In the last couple of years, Biogen has brought in new leadership to head up the company's R&D and venture arms. The aim is to rebuild Biogen's long-term pipeline, as Head of Immunology Research Nick Wilson, Ph.D., told Fierce, in a "fundamental difference in how we're approaching our research engine."... Full

 

Adaptive Plots Splitting Pfizer-Partnered Drug Discovery Unit from Diagnostics Business

(6/16, Nick Paul Taylor, Fierce Biotech) ...The company will focus on the profitable diagnostics business and explore alternatives for the medicine unit, it said in a June 16 release... Full

 

Merck Inks $510m Biobucks Data Generation Partnership with Protillion

(6/16, Will Maddox, Fierce Biotech) ...Protillion will receive an undisclosed upfront payment, with the potential to earn research, development and commercial milestones tied to the successful development of multiple therapies, according to a June 16 release... Full

 

 

FDA, UK Drug Regulator Deepen Transatlantic Ties with New Liaison Program

(6/16, Zoey Becker, Fierce Pharma) ...The United Kingdom's Medicines and Healthcare products Regulatory Agency (MHRA) and the U.S. [FDA] are forging a new regulatory collaboration, setting up a liaison program to foster faster collaboration between the two countries when thorny drug and technology questions arise... Full

 

Analysis-Big Pharma Taps UK Playbook to Pressure European Capitals on Drug Prices

(6/17, Maggie Fick, Bhanvi Satija, Reuters) ...Global pharmaceutical companies, facing pushback from European capitals on drug pricing, are turning to a playbook that brought them recent success in Britain: threats of pulling investment and expansion plans to pressure policymakers... Full

 

GBMA Joins High Court Patent Extension Case

(6/17, Retail Pharmacy) ...The Generic and Biosimilar Medicines Association (GBMA) has been granted leave to intervene as a 'friend of the court' in a High Court case that could have significant implications for Australia's pharmaceutical patent system. The case, Otsuka Pharmaceutical Co., Ltd & Ors v Sun Pharma ANZ Pty Ltd, which was heard on June 16 and continues today (June 17), centres on whether patents covering pharmaceutical formulations can qualify for patent term extensions beyond the standard patent period... Full

 

Alberta Strikes New Deal With Pharmacists, Dispensing Fees to See Small Bump

(6/16, The Canadian Press) ...Primary Health Minister Justin Wright says the government has signed a new three-year funding agreement with pharmacists, and as part of the deal Alberta is increasing dispensing fees for the first time in a decade...The government says the new agreement will see pharmacist compensation be boosted three per cent in each of the first two years and before a rate review is done in the final year based on how successful the deal is... Full

 

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