Friday, June 5, 2026

 

 

Teva Joins EU Aflibercept Party

(6/5, Dean Rudge, Generics Bulletin) ...The Israeli firm said the rollout of Ahzantive pre-filled syringes had begun in May across France, Germany, Spain and the Netherlands, with launches in further markets expected later this year...Further product rollout in additional Central and Eastern European countries will occur over the upcoming weeks and months, the firm said, while an aflibercept vial presentation will be introduced in select European regions over the coming months... Global Sub. Full

 

Teva Launches Ahzantive Aflibercept Biosimilar for Retinal Diseases in Europe

(6/4, Emily Schoenthaler, BioPharmInternational.com) ..."Biosimilars play a critical role in sustainable healthcare systems," Yolanda Tibbe, global head of biosimilars at Teva, said in the release. "With this launch, we are expanding our biosimilars portfolio with an important treatment option for people living with serious conditions that can threaten sight."... Full

 

 

Roche Chair Accuses US Government of Drug Price 'Blackmail'

(6/4, Fabienne Kinzelmann, Bloomberg) ..."A deal is a two-way street. If someone puts a gun to your head and says, 'If you don't sign this we will have 200% tariffs starting tomorrow,' that's not a deal," [Roche Holding AG Chairman Severin Schwan,] said, speaking at the high-profile Swiss Economic Forum in Interlaken on Thursday. "It might be an agreement in a legal sense, but it's basically blackmail, there's no other way to put it. It's the law of the jungle, trying to get their way by any means necessary."... Full

 

US Supreme Court Backs Generic Drugmaker in 'Skinny Label' Patent Case

(6/4, Blake Brittain, Reuters) ...Lauren Aronson, executive director of the interest group Campaign for Sustainable Rx Pricing, said that Thursday's decision "helps restore certainty to the skinny-label pathway and will encourage more lower-cost generic competition to enter the market more quickly."... Full

 

SCOTUS Backs Generic Firm Hikma in Skinny Label Dispute

(6/4, Phil Taylor, Pharma Phorum) ...The White House supported Hikma's appeal, which seems to have laid to rest some legal uncertainty over the skinny label issue that remained after earlier cases, including GSK's tussle with Teva over the cardiovascular drug Coreg (carvedilol) and Gruenenthal vs Alkem over opioid therapy Nucynta ER (tapentadol hydrochloride)... Full

 

US Supreme Court Backs Hikma In Landmark Skinny-Label Generic Ruling

(6/4, Dave Wallace, Generics Bulletin) ...In a footnote, the court also referred to earlier litigation between GSK and Teva revolving around Teva's skinny-label generic version of the originator's Coreg (carvedilol), noting that in that case the Federal Circuit had "increasingly trained its focus on whether the relevant statements could be read by medical providers as instructions to infringe."... Global Sub. Full

 

Editorial: The Supreme Court Refutes Its Critics

(6/4, The Wall Street Journal) ...These decisions contradict the left's canard that conservative Justices are on a mission to "gut" the administrative state. No, the Justices are applying the law and precedents as they read them... Sub. Req'd

 

It's Time for Congress to End Big Pharma's War on Generics

(6/4, David Marin, Washington Examiner) ...Patents should be a shield to protect innovation, not an impenetrable, everlasting wall to protect profits. Let's reform a system that forces people to sacrifice their health and financial security to grow brand drugmaker profits. End the war on generics... Full

 

Unconstitutional Drug Pricing Demands Fifth Circuit Intervention

(6/5, Alice LaCour, Bloomberg Law) ...The Inflation Reduction Act's drug pricing scheme is a textbook example of Congress delegating sweeping authority to an unaccountable agency. That isn't a democratic value, and it doesn't need to be defended as one... Full

 

After Multiple Hearings, Witnesses Tell Congress It's Time to Act on Foreign Drug Quality

(6/4, Lisa Fletcher, Andrea Nejman, Lucas Masiello, WJLA) ...Twenty years ago, whistleblower Dinesh Thakur helped expose one of the biggest generic drug fraud cases in history involving Indian drug manufacturer Ranbaxy. At the hearing, Thakur thanked lawmakers for focusing on the issue but noted that little has changed to protect Americans from badly made foreign drugs. Thakur told senators that many of the same problems that existed when he first blew the whistle in 2014 continue to appear in FDA inspection reports... Full

 

Trump Admin Vetting Critic of RFK Vaccine Policies for FDA Chief, Sources Say

(6/4, Adam Cancryn, Sarah Owermohle, CNN) ...The Trump administration is vetting a first-term health official to lead the Food and Drug Administration who has criticized vaccine policies championed by Health and Human Services Secretary Robert F. Kennedy Jr. Dr. Norman "Ned" Sharpless, who ran the National Cancer Institute during President Donald Trump's first term, is one of a handful of outside candidates under consideration for the permanent job, four people familiar with the matter said... Full

 

HHS Looks To Preserve Some Makary-Era Reforms As US FDA Commissioner Pick Looms

(6/4, Maaisha Osman, Pink Sheet) ...Chris Klomp, CMS deputy administrator and Health and Human Services Department senior advisor, said Makary left "a number of outstanding reforms" and described the former commissioner's agenda as an "incredible playbook." He said final recommendations for FDA commissioner should go to President Trump in the coming weeks. Another White House official told the Pink Sheet that the administration is looking for FDA leaders who can carry forward at least parts of Makary's policy agenda... Global Sub. Full

 

Stakeholders Offer Suggestions for Improving FDA's CNPV Program

(6/4, Jeff Craven, Regulatory Focus) ...While most speakers were supportive of the intent and goals of the program, other organizations raised concerns over the CNPV pilot, citing issues with the voucher selection process, the review timelines, transparency, and politicization of the program... Full

 

Freiman Bill to Eliminate Barriers to Lower-Cost Prescription Drugs Clears Committee

(6/4, New Jersey Assembly Democrats) ...Bill A1510 would require the State Health Benefits Program, School Employees' Health Benefits Program, and Medicaid managed care plans to cover biosimilars, safe, FDA-approved alternatives to brand-name biologics, with more favorable cost-sharing than the brand-name drug whenever the net cost to the patient is lower... Full

 

Delaware Governor Meyer on Drug Pricing, Reshoring, and National Security

(6/4, Zachary Zubulake, PharmTech) ...As a part of CPHI Americas, Delaware Governor Matt Meyer sat down with PharmTech to make the case that domestic pharmaceutical manufacturing is far more than an economic issue, it's a matter of national survival. Drawing on lessons from the COVID-19 pandemic, Meyer argues that the US can no longer afford to depend on foreign suppliers for its most critical medicines and medical equipment... Full

 

AbbVie Loses Latest Challenge Against Mississippi Pharmacy Law

(6/4, Ganny Belloni, Bloomberg Law) ...The US District Court for the Southern District of Mississippi on Wednesday denied the pharmaceutical company's request for summary judgment blocking enforcement of Mississippi's Defending Affordable Prescription Drug Costs Act and granted the state attorney general's move to dismiss the case...At issue in this case was the state's prohibition on drug manufacturers limiting pharmacies' acquisition of drugs discounted under the federal 340B drug discount program... Full

 

A Pharmaceutical Company Is Trying to Block Colorado's First-in-the-Nation Drug Price Cap in Court

(6/5, John Ingold, The Colorado Sun) ...In addition to the PDAB, [Gov. Jared] Polis championed a plan to import lower-cost prescription drugs from Canada. He backed health insurance initiatives like a program called reinsurance that helps insurance companies pay their highest-cost claims, as well as a government-designed insurance plan called the Colorado Option. But, as the Polis administration nears its end, the fate of all those initiatives is uncertain... Full

 

 

Autobahn Races Toward Pivotal Trial after Thyroid Hormone Mimic Eases Bipolar Depression in Ph. 2

(6/4, Darren Incorvaia, Fierce Biotech) ...A stimulator of thyroid hormone receptors in the brain has successfully reduced depression severity in patients with bipolar disorder, positioning its maker Autobahn Therapeutics to speed along to late-stage testing with its ultimate goal of approval resting further ahead at the finish line. Autobahn reported this morning that elunetirom, an oral small-molecule given once daily, eased depression severity by an average of 16.8 points after six weeks, as measured by the Hamilton Depression Rating Scale... Full

 

 

FDA Clears Amneal's Ready-to-Use Romidepsin, Filling Gap Left by Teva's Withdrawal

(6/4, Denise Myshko, Managed Healthcare Executive) ...The FDA has approved Amneal Pharmaceuticals' romidepsin, a ready-to-use injection to treat adults with cutaneous T-cell lymphoma and who have received at least one prior systemic therapy. Romidespin is eligible for competitive generic therapy (CGT) designation, which provides Amneal with 180 days of market exclusivity...Amneal's ready-to-use formulation of romidepsin references the romidepsin product that was previously marketed by Teva. Teva's withdrawal of romidepsin was tied to the withdrawn of an indication to treat patients with peripheral T cell lymphoma... Full

 

Generic Semaglutide Is Now Available in Canada. Where Is the Medication Available and Is it Actually Cheaper? Demand Is High for Generic Versions of Ozempic, Currently the Best-Selling Drug in Canada

(6/4, Arisa Valyear, The Globe and Mail) ...Shoppers Drug Mart and Rexall said they have started to receive generic semaglutide at some of their locations. Digital health care platforms and medication suppliers, including Felix, also offer the generic drug. The medication is offered as a pen that contains four weekly injections...Four additional manufacturers (Sandoz Canada Inc., Taro Pharmaceuticals Inc., Aspen Pharmacare Canada Inc. and Teva Canada Ltd.) are still being reviewed by Health Canada for approval to begin making generic semaglutide. Vimy Pharma, a new Toronto-based drug company, recently told The Globe and Mail they have also filed an application... Sub. Req'd

 

Axsome Fends Off Generic Competition to Narcolepsy Med Sunosi Until 2040

(6/4, Zoey Becker, Fierce Pharma) ...Through the settlements, five companies will be cleared to market their generic versions of Sunosi starting on September 1, 2040, if Axsome nabs a pediatric exclusivity period for the drug. If not, the knockoffs can launch on March 1, 2040, the company explained. With that, "no other patent litigation relating to Sunosi remains pending."... Full

 

Kashiv BioSciences Announces Validation and Acceptance of Market Authorization Application by Health Canada for ADL-018, a Proposed Biosimilar to XOLAIR® (Omalizumab)

(6/4, Kashiv BioSciences) ..."The acceptance of this submission by Health Canada marks a key regulatory milestone for Kashiv's biosimilars portfolio," said Dr. Sandeep Athalye, Global CEO of Kashiv BioSciences. "It reflects the strength of our development and manufacturing capabilities and brings us closer to making the omalizumab biosimilar available to patients in Canada. We remain focused and committed to expanding access to high-quality, cost-effective biologic therapies globally."... Full

 

Lupin Receives USFDA Approval for Ranluspec Biosimilar Referencing Lucentis

(6/4, Jomy Jos Pullokaran, CNBC TV18) ...Both the vial and pre-filled syringe formats have been approved in the two strengths available for Lucentis: 0.3 mg (0.05 mL of 6 mg/mL) and 0.5 mg (0.05 mL of 10 mg/mL). Ranibizumab is a recombinant humanised IgG1 monoclonal antibody fragment that binds and inhibits vascular endothelial growth factor A... Full

 

PBIRx Hosts Webinar: Biosimilars - The New Savings Frontier for Prescription Drug Benefits

(6/4, PBIRx) ...PBIRx, a national leader in pharmacy benefit consulting and auditing, hosted an insightful webinar today, Biosimilars: The New Savings Frontier, providing actionable insights into the biosimilar market landscape, regulatory influences, and PBM strategies for plan sponsors... Full

 

Breckenridge Announces Launch of Tofacitinib Tablets, Generic Equivalent of Xeljanz® by Pfizer

(6/4, Breckenridge Pharmaceutical) ...Tofacitinib Tablets are available in 5 mg and 10 mg strengths and provide a flexible dosing option to support individualized treatment approaches across approved indications... Full

 

 

Pfizer Signs Licence Agreement with Chai for AI Drug Discovery

(6/5, Salong Debbarma, Pharmaceutical Technology) ...According to the agreement, Pfizer will become one of the first pharmaceutical companies to access Chai's newly revealed Chai-3 model. This AI model reportedly delivers significant advances in AI-led antibody design, including a doubled success rate compared to its predecessor, production of therapeutically viable antibodies, and enhancements in targeting difficult-to-drug molecules... Full

 

Alnylam, Inceptive ink AI Deal Potentially Worth $2B

(6/4, Kristin Jensen, BioPharma Dive) ...The deal is the latest example of how AI is reshaping the pharmaceutical industry. Proponents tout that the technology will help quickly zero in on therapies with the most promise. Inceptive CEO Jakob Uszkoreit goes a step further, saying his company's technology, in partnership with Alnylam, is "changing the way we understand and improve life."... Full

 

1 Big Thing: Medical Innovation's Big Moment

(6/5, Caitlin Owens, Axios) ...Modern medicine has transformed once-deadly conditions into chronic ones, and further progress would be even more meaningful to the patients who suffer from them and their loved ones. But the next frontier of medicine is to cure more diseases - or prevent them altogether... Full

 

 

Target Is to Boost India's Share in Global Pharmaceutical Trade to $450 Billion by 2047: Drugs Controller General

(6/4, The Hindu) ...Rajeev Singh Raghuvanshi, Drugs Controller General of India, said the country has set a target of achieving $450 billion by 2047 in global pharmaceutical trade as per the vision of Prime Minister Narendra Modi's Viksit Bharat... Full

 

India Should Take Action Against US Tariff Barrage

(6/4, Sangeetha G, Deccan Chronicle) ...India's drug regulator has directed pharmaceutical companies across the country to immediately put in place a pharmacovigilance system to track and report adverse drug reactions, warning that compliance will be scrutinised during routine inspections. The Central Drugs Standard Control Organisation (CDSCO) said all drug manufacturers, marketers and importers must establish and maintain such systems in line with existing regulations, amid increasing scrutiny of India's post-market drug safety surveillance framework... Full

 

EU Pilot Shows 70-Day Multinational Trial Approvals Possible, EFPIA Calls For Consistency

(6/4, Vibha Sharma, Pink Sheet) ...The research-based pharmaceutical industry federation, EFPIA, told the Pink Sheet that while the results demonstrate the EU's ability to deliver faster reviews, these timelines must be applied systematically rather than remaining confined to a pilot... Global Sub. Full

 

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