Thursday, June 11, 2026

 

 

Teva Acquires Emalex For $700 Mln; Ecopipam NDA Planned In H2 2026

(6/11, RTTNews) ...Teva...announced the completion of its acquisition of Emalex Biosciences for a consideration of $700 million, with the potential for up to an additional $200 million in commercial milestone payments, among other contingent payments. The acquisition adds Ecopipam, an investigational asset for pediatric Tourette syndrome, to Teva's pipeline... Full

 

 

Voters Lean in Favor of Codifying Trump's MFN Policy

(6/10, Joseph Choi, Nathaniel Weixel, The Hill) ...Nearly 6 in 10 voters said they believe prescription drug prices have not gone down enough, and the federal government needs to do much more to reduce prices. Nine in 10 said it's important for Congress to act... Full

 

Big Pharma Lost in Court - Congress Must Not Bail it Out

(6/10, Merith Basey, The Hill) ...The courts declined to give pharmaceutical companies the carve-out they were asking for. Congress shouldn't either. Patients in every other wealthy country already get the medications they need at prices their governments negotiated on their behalf. Americans deserve the same - and they finally have a law that delivers it. Congress must protect and expand it... Full

 

BIOSECURE Legal Lifeline Available For Pharma Companies Using WuXi AppTec … For Now

(6/10, Maaisha Osman, Pink Sheet) ...The BIOSECURE Act includes a five-year grandfathering period for contracts or contract options already in place before the prohibitions take effect for a BCOC. The five-year clock begins from the date the Federal Acquisition Regulation (FAR) is revised to implement the law's requirements, which remains far off. Under the statutory timeline, the Office of Management and Budget must publish its formal BCOC list by December 2026, then issue implementing guidance within 180 days. The FAR Council then has one year to revise the FAR... Global Sub. Full

 

AMA Holds Off On Endorsing 340B-Priced Drugs For Private Practice Patients

(6/10, Gabrielle Wanneh, Inside Health Policy) ...Following a vote at AMA's House of Delegates annual meeting this week, members decided the policy and its implications needed to be studied further before taking a definitive stance, opting instead to reaffirm the association's current policy supporting efforts to improve 340B program oversight. The physician lobby group also said it will work with the Health Resources and Services Administration (HRSA) to establish 340B eligibility for all practices committed to serving low-income, rural and otherwise underserved communities... Sub. Req'd

 

BsUFA IV: US FDA Willing To Select Products For Exclusivity Determinations Each Year

(6/10, Derrick Gingery, Pink Sheet) ...FDA officials only would commit to "publishing a limited number" of exclusivity determinations annually, according to meeting minutes. The agency would increase the total "once during BsUFA IV." The FDA also wants to select the products that would receive an exclusivity determination... Global Sub. Full

 

Prescription Drug Costs Loom in Midterms

(6/10, Francisco Raul "Quico" Canseco, RealClearHealth) ...As the 2026 midterms approach, Democrats intend to campaign aggressively on affordability and will direct sustained attention to prescription drug costs in every competitive district in the country. Republicans who champion market solutions do not merely blunt that argument, they can remove it entirely... Full

 

In Case You Missed It… Sen. Rick Scott Sits Down With Punchbowl to Talk Onshoring Drug Manufacturing and National Security

(6/10, Senator Rick Scott) ...Senator Rick Scott, Chairman of the U.S. Senate Special Committee on Aging, participated in a conversation with Punchbowl News' Jake Sherman yesterday to discuss onshoring American drug manufacturing and spotlighted the need for the Consumer Labeling for Enhanced API Reporting and Legitimate Accountability for Base Entity Listings (CLEAR LABELS) Act. They also discussed the national security implications of relying on drugs made in China, as well as next steps for reauthorizing the Foreign Intelligence Surveillance Act (FISA)... Full

 

Drugmakers Lose Effort to Block Washington Pharmacy Law

(6/10, Ganny Belloni, Bloomberg Law) ...The US District Court for the Western District of Washington on Tuesday denied requests from AbbVie Inc., AstraZeneca PLC, Novartis AG, and the Pharmaceutical Research and Manufacturers of America seeking a preliminary injunction blocking enforcement of the state's S.B. 5981, a law that prohibits manufacturers from imposing limitations on a pharmacy's participation in the federal 340B drug discount program... Full

 

 

Takeda's $4B TYK2 Drug Tops Bristol Myers' Sotyktu in Head-to-Head Test

(6/11, Jonathan Gardner, BioPharma DIVE) ...Takeda didn't provide detailed data, but said that zasocitinib demonstrated statistical superiority against Sotyktu on all main and secondary study goals. After 16 weeks, zasocitinib helped completely eliminate the skin lesions in over a third of recipients, more than doubling what was seen with Sotyktu. It's the second time Takeda's drug has beaten an approved therapy, following positive results in a trial testing it against Amgen's Otezla... Full

 

AbbVie's Migraine Drug Cleared for Migraine Attacks on NHS

(6/10, Phil Taylor, PharmaPhorum) ...The recommendation is based on results from ECLIPSE, a phase 3 study in which 24.3% of patients treated with atogepant were free of pain two hours after dosing, following the first migraine attack, compared with 13.1% for placebo. The recommendation has been welcomed by The Migraine Trust, whose chief executive, Rob Music, described Aquipta as a much-needed alternative for people who have not had success with or aren't able to tolerate other medications... Full

 

 

Organon Wins US Approval to Widen Use of Arthritis Biosimilar Drug

(6/10, Reuters) ...Organon said Tofidence can now be used in adults and children aged two years and older for both conditions... Full

 

Lupin Launches Continue To Multiply

(6/11, Anabel Costa-Ferreira, Generics Bulletin) ...Lupin has announced the US Food and Drug Administration approval for its ranibizumab product, Ranluspec, as an interchangeable biosimilar referencing Genetech's Lucentis. Ranluspec is the only interchangeable biosimilar ranibizumab approved in the US for both vials and pre-filled syringes (PFS). Both the vials and PFS have been approved across strengths 0.3mg (0.05ml of 6mg/ml), and 0.5mg (0.05ml of 10mg/ml)... Global Sub. Full

 

Lupin's COPD Inhaler Spreads Further In Europe

(6/10, Dean Rudge, Generics Bulletin) ...Lupin has launched Luforbec in Spain with Laboratorios ERN, adding to earlier UK and Germany introductions and broadening its European respiratory portfolio for adult asthma and COPD...The partnership of Lupin and ERN brings together Lupin's respiratory and pMDI manufacturing capabilities with the Spanish firm's national reach and customer relationships, according to the firms... Global Sub. Full

 

Nexus Faces Five Year Wait On Injectable Minocycline

(6/11, Dean Rudge, Generics Bulletin) ...Nexus Pharmaceuticals will have to wait until patent expiry in 2031 to launch its proposed generic version of CorMedix Therapeutics' intravenous antibiotic Minocin (minocycline), after the US Court of Appeals for the Federal Circuit affirmed that the generics firm's product infringes a valid patent... Global Sub. Full

 

Biosimilars & Patient Access Independent of Geographies or Socioeconomics, With Rebecca Guntern

(6/10, Nicole Raleigh, PharmaPhorum) ...[Rebecca Guntern, chief commercial officer at Sandoz,] discusses why the current wave of blockbuster biologics losing exclusivity is so significant for patient access and healthcare budgets, and the conversation also touches upon policy and regulatory changes still needed in order to unlock the full potential of biosimilars, as well as what should be expected from the next generation of biosimilars... Full

 

 

Pharma Backlash to German Reforms Deepens as Pfizer Rethinks Investment Plans

(6/10, Anna Bratulic, FirstWord PHARMA) ...Pfizer is reportedly reviewing the timing and scope of planned investments in Germany, joining a growing list of drugmakers warning that proposed healthcare reforms in the country could erode the appeal of one of Europe's largest pharma markets. The warning from Pfizer CEO Albert Bourla was outlined in a letter this week to German Chancellor Friedrich Merz and reported by Handelsblatt on Wednesday... Full

 

Cipla Wants New-Age Medicines to Contribute 10% of Revenue in Five Years

(6/10, Ekta Batra, CNBC TV18) ..."A lot of our mainstay revenues in the years to come, maybe five years or 10 years, will still stay in generics because that's where we serve the maximum number of patients," [CEO Anchin Gupta] said. While generics will remain central to the company's business model, Cipla is targeting a larger contribution from innovative products and technologies, building on recent launches in India across respiratory and other therapy segments. "If you ask me, in five years, we would love to have 10% of our revenues come from innovation," Gupta said... Full

 

Apotex Stock Soars Following Company's $932 Million IPO

(6/11, Robb M. Stewart, The Wall Street Journal) ...Apotex's offering consists of a treasury offering of about 35.4 million shares for gross proceeds of about C$850 million, and a secondary offering of stock by certain shareholders for proceeds of C$450 million that will go to those investors. The selling shareholders have granted the underwriters of the IPO the right to buy up to an additional 8.1 million shares at C$24 apiece to cover any overallotment... Sub. Req'd

 

PSG Report Examines Payers and Employers' Attitudes Towards GLP-1 Coverage, Unbundling' PBM Models

(6/10, Cailey Gleeson, Fierce Healthcare) ...The 2026 Trends in Drug Benefit Design report drew insights from a survey of 237 benefits leaders across employers, health plans and unions... Full

 

 

5 Countries Call for United EU Response to Trump's Drug Price Threats

(6/10, Rory O'Neill, Politico) ...EU countries should align drug pricing policies and resist scattergun responses to pressure on medicine costs, according to a statement from five governments. Belgium, the Netherlands, Luxembourg, Austria and Ireland - members of the Beneluxa initiative - said on Wednesday they favor collaboration on "shared structural challenges" and warn against "uncoordinated individual national responses."... Full

 

Biosimilars Reshape Immunology Care Across EU a Decade After Market Entry

(6/11, Nicole Verbeeck, Euractiv) ...According to a recent report led by KU Leuven under the MABEL project, off-patent biologics and biosimilars now account for approximately 70 per cent of the volume of biologic medicines used across Europe, collectively treating an estimated 12 to 15 million patients annually...The same KU Leuven report found that biosimilar treatment days per 100,000 inhabitants for 11 molecules in EU26 Member States increased from 220 in 2019 to 540 in 2024, more than doubling over five years... Full

 

Industry Urges EU To Broaden SPC Scope Under Biotech Act

(6/10, Eliza Slawther, Pink Sheet) ...If legislators amending the Biotech Act were to expand the scope and eligibility criteria for SPCs proposed in the draft law, it could increase R&D investment from €4bn ($4.6bn) to €45bn over 15 years, according to an EFPIA-commissioned report by Copenhagen Economics, a Danish consultancy firm... Global Sub. Full

 

UK MHRA Urges Human Oversight As AI-Generated Inspection Responses Cite Fake Regulations

(6/10, Vibha Sharma, Pink Sheet) ..."We want to encourage innovation, use of technology," but there have been examples where AI-generated inspection responses "have included non-existing regulation" and multiple pages of materials that "aren't relevant to the original [inspection] findings," said the MHRA's Stephen Vinter. The agency plans to publish a blog on the use of AI in responding to inspection findings in the coming weeks, according to Vinter, head of the MHRA's Compliance Team... Global Sub. Full

 

Pharma Exports to Clock $50 Billion by 2030: Ministry Official

(6/10, The Hindu Businessline) ...India's affordability remains India's defining strength, [Mohit Yadav, Joint Secretary, Department of Commerce,] said, pointing to Indian generic medicines that had contributed to making medicines accessible across the world. India is the third-largest producer of pharmaceuticals by volume, supplies around 20 per cent of global generic medicines demand, and exports pharmaceutical products to more than 200 countries and more than 60 per cent of India's pharmaceutical exports go to stringently regulated markets, he pointed out in a statement... Full

 

Govt Approves Price Hike for Cancer Drugs Amid Nationwide Shortage

(6/11, Sanket Koul, Business Standard) ...The Centre has given in-principle approval to the National Pharmaceutical Pricing Authority (NPPA) to allow price increases for cancer drugs Cisplatin and Carboplatin, as shortages continue to disrupt supplies at hospitals across the country, according to sources close to the development... Full

 

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