Tuesday, July 14, 2026

 

 

US Appeals Court Revives Teva Lawsuit Over Lilly Osteoporosis Drug

(7/13, Blake Brittain, Reuters) ...The Chicago-based 7th U.S. Circuit Court of Appeals reversed a lower court's decision that had found the agreement expired before Lilly allegedly broke it, giving Teva a new chance to prove that Lilly breached their contract... Full

 

Teva Lawsuit Over Generics of Lilly's Forteo Brought Back by Appeals Court

(7/14, Jonathan Block, Seeking Alpha) ...The two drugmakers brokered a settlement agreement in 2018 that allowed Teva to launch its generic teriparatide as early as 2019. The US FDA eventually granted Forteo an additional three years of exclusivity in 2020. Teva began marketing its generic version in December 2023, according to Reuters...Teva then sued Lilly in 2024, alleging that the extra exclusivity period delayed its generic marketing... Full

 

 

What Germany's Drug Rebate Hike Means for US Pharma

(7/13, Stephen Appezzato, Pharmaceutical Commerce) ...The immediate effect is a margin cut on branded sales in one of the world's largest pharmaceutical markets, with knock-on risk to European launch sequencing if companies deprioritize Germany as launch economics deteriorate. The larger implication is transatlantic. By cutting what it pays for patented drugs, Germany widens the gap between US and European prices, the very gap at the heart of the Trump administration's most-favored-nation push to tie US prices to lower benchmarks abroad... Full

 

FDA Proposes to Streamline Registration of Drugmakers' Foreign and US Factories

(7/14, Anna Brown, Endpoints News) ..."We are currently reviewing FDA's proposed rule and working closely with our member companies to assess its potential impact," a spokesperson from the Association for Accessible Medicines told Endpoints News. "We'll be evaluating whether the proposal strengthens supply chain resilience, supports efficient manufacturing, and avoids creating unnecessary burdens or unintended consequences for manufacturers and ultimately for patient access to affordable medicines."... Sub. Req'd

 

Only Two Generic Drug Makers At Administration's Essential Medicine Production Meeting

(7/13, Maaisha Osman, Pink Sheet) ...The administration is considering financial, purchasing and FDA regulatory incentives to support US production of finished drugs, APIs and key starting materials... Global Sub. Full

 

Over 290,000 Stakeholders Weigh In On OMB Grant Rule

(7/13, Lauren Brensel, Inside Health Policy) ...In a comment shared with Inside Health Policy, a spokesperson for OMB said the changes would not replace peer review. "This rule is fundamentally about accountability to the American people and ensuring that taxpayer dollars are spent wisely," they said. "Officials who are accountable to the President and ultimately the American people will give final approval before grants go out the door."... Sub. Req'd

 

Getting Compliance Right: Parexel's McDavid On 483s, CRA Accountability and CGT

(7/14, Anju Ghangurde, Pink Sheet) ...Misinterpreting FDA 483 observations from a bioresearch monitoring inspection is costly - clarity on what the agency has documented drives every downstream decision, indicates Cris McDavid, Parexel's executive director, global clinical data operations, risk-based quality management (RBQM) and integrated data delivery... Global Sub. Full

 

US FDA Promotes Deputy To Acting Chief Information Officer

(7/13, Derrick Gingery, Pink Sheet) ...Sanjay Kumar Sahoo has been named acting FDA chief information officer, according to the agency's website. In addition to leading the agency's IT strategy, he also will handle enterprise IT, data management and cybersecurity... Global Sub. Full

 

 

Exit of Roche's Embattled Huntington's Drug 'Tightens' Case for Wave's More Selective ASO

(7/13, Heather McKenzie, BioSpace) ...Investment banking firm Rodman & Renshaw attributed the failure to tominersen's mechanism of action, lowering both mutant and wild-type huntingtin (HTT) protein. "We believe this non-selective knockdown, sustained over 16 months, is the most likely driver of the lack of clinical benefit despite clear target engagement," the analysts wrote in a letter to investors on Friday... Full

 

Bristol Myers Squibb's New Drug Application for Mezigdomide Accepted by FDA

(7/13, PMLiVE) ...The application is based on results from the phase 3 SUCCESSOR-2 trial showing oral CELMoD mezigdomide, in combination with carfilzomib and dexamethasone (MeziKd), significantly improves progression-free survival in patients with relapsed or refractory multiple myeloma (RRMM) vs standard of care... Full

 

GSK to Seek FDA Approval for Jemperli in Small but High-Profile Cancer Use after Phase 2 Win

(7/13, Angus Liu, Fierce Pharma) ...In what GSK says represents a potential way to transform treatment for patients with certain types of rectal cancer, the company's Jemperli has met the main goal of a phase 2 trial, teeing up an application with the FDA. Interim results from the phase 2 AZUR-1 study showed a "meaningful and sustained" clinical complete response rate for Jemperli at 12 months in stage 2/3 mismatch repair deficient/microsatellite instability-high (dMMR/MSI-H) locally advanced rectal cancer, GSK said Monday... Full

 

FDA Approves At-Home Starting Dose for Lecanemab, Marking First Subcutaneous Initiation Option for Alzheimer Disease Treatment

(7/13, Marco Meglio, Neurology Live) ...According to an announcement, the FDA has approved a subcutaneous starting dose regimen for lecanemab-irmb (Leqembi; Eisai/Biogen), allowing patients with early Alzheimer disease (AD) to initiate treatment at home via weekly self-injection for the first time. The decision marks a meaningful shift in how the therapy can be delivered, removing the prior requirement that patients complete 18 months of intravenous infusions before becoming eligible for at-home subcutaneous dosing... Full

 

 

Mint Explainer | Why Are Generic Weight Loss Drugs Losing Steam?

(7/13, Jessica Jani, Mint) ...After an initial surge, generic semaglutide brands have begun to plateau, according to monthly sales data...Generic brands did expand the market significantly in terms of volume-they accounted for 82% of total unit sales in June. However, the expansion may already be optimally covered, with no further exponential growth, according to the Pharmarack report. Patients who couldn't access innovator drugs may have already been onboarded, and now the challenge is retaining them... Full

 

OneSource Specialty Pharma and Formycon AG Ink Manufacturing Pact for Biosimilars

(7/14, Pharmabiz.com) ...Under the partnership, OneSource will serve as a strategic manufacturing partner for Formycon and provide integrated drug substance (DS) and drug product (DP) manufacturing capabilities from its state-of-the-art biologics' facility in Bengaluru. The collaboration brings together Formycon´s biosimilar development excellence with OneSource's end-to-end biologics manufacturing expertise to support Formycon's biosimilar programmes for global markets... Full

 

Clean FDA Review Sharpens NRx Ketamine Commercial Case

(7/13, Dean Rudge, Generics Bulletin) ...NRx Pharmaceuticals is continuing to point to a potential US approval for its preservative-free ketamine product later this year after the US [FDA's] Office of Generic Drugs raised no major issues across several key review disciplines, including bioequivalence. The Delaware-based company expects an FDA decision in the current quarter ending September 30 for its abbreviated new drug application for Ketafree, a proposed preservative-free intravenous ketamine product... Global Sub. Full

 

A.forall Announces ANDA Approval for Sodium Bicarbonate for Injection, USP

(7/13, A.forall) ...A.forall announced through its U.S. subsidiary, Milla Pharmaceuticals Inc., that it has received Abbreviated New Drug Application (ANDA) approval by the U.S. [FDA] for 8.4% Sodium Bicarbonate Injection, USP 50 mEq/ 50 mL vials for intravenous use... Full

 

 

AstraZeneca Adds Another Chinese Asset, from Dizal

(7/14, Phil Taylor, pharmaphorum) ...AstraZeneca has continued its pipeline-boosting deal spree in China with a $1.5 billion agreement that gives it global rights to Dizal Pharma's lung cancer therapy Zegfrovy. Zegfrovy (sunvozertinib) - an oral irreversible EGFR inhibitor - is already approved in China and the US as a second-line treatment for adults with locally advanced or metastatic non-small cell lung cancer (NSCLC) with exon 20 insertion mutations who have previously had platinum-based chemotherapy... Full

 

Mylan to Sell Up to $363 Million Stake in India's Biocon, Term Sheet Shows

(7/13, Yantoultra Ngui, Reuters) ...Mylan Inc, part of a global healthcare company Viatris, plans to sell up to 92 million shares in Indian drugmaker Biocon Ltd, worth up to 34.81 billion Indian rupees ($363 million), according to a term sheet seen by Reuters... Full

 

In Latest Deal, Innovent Seeds Spero's Future Beyond GSK-Owned Antibiotic

(7/14, Kyle LaHucik, Endpoints News) ...An autoimmune drug candidate from the Suzhou, China-based biopharma is laying the foundation for Spero Therapeutics' future beyond a GSK-partnered antibiotic that secured FDA approval last month... Sub. Req'd

 

Chai's AI Tech Hooks Another Big Pharma Partner in Deal with Novartis

(7/13, Elizabeth S. Eaton, FirstWord PHARMA) ...Under the agreement, Novartis will gain access to the AI firm's latest model, Chai-3. Unveiled in June, the AI model improves upon the antibody design capabilities of Chai-2, boasting double the success rate of its predecessor and the ability to speed up discovery activities... Full

 

Biopharma's 'Extraordinary Year' for M&A Sets Tone as Earnings Cycle Begins

(7/13, Max Gelman, Endpoints News) ...With the first half of 2026 officially in the books and another earnings season about to begin, a key question hangs over the biopharma industry: Will the good times continue? The answer to that may reside in the booming M&A market, which is coloring the background as second-quarter reports get underway this week, starting with Johnson & Johnson on July 15. Nearly four dozen acquisitions took place between January and June, from small bolt-ons to multiple $10 billion-plus buyouts. The dealmaking enthusiasm has spilled over into the markets as well, with the XBI up about 30% year-to-date to the $160 range, approaching the all-time high set in February 2021... Sub. Req'd

 

 

Switzerland and UK Agree Trade Deal to Deepen Post-Brexit Ties

(7/13, Bastian Benrath-Wright, Lucy White, Bloomberg) ...Switzerland and the UK concluded talks on an updated free-trade agreement, bringing Western Europe's two major non-European Union economies closer together with a pact focused on services. Both countries announced the completion of negotiations on Monday, slightly more than three years after they started. Building on a 2023 financial services agreement, the accord is intended to make it easier for firms in finance, technology, pharmaceuticals and legal services to operate across borders... Sub. Req'd

 

Speedy Review For UK Phase I Trial Applications Imminent Under MHRA Economic Growth Goals

(7/13, Neena Brizmohun, Pink Sheet) ...The UK's Medicines and Healthcare products Regulatory Agency (MHRA) intends to adopt a stepwise, 14-day assessment pathway for Phase I clinical trial applications by the end of 2026, a move that it expects will be a key draw for global developers deciding where to base their research... Global Sub. Full

 

Biosimilars Pass Their Decade Test as Regulators Settle the Safety Question

(7/13, Nicole Verbeeck, Euractiv) ...The European Medicines Agency, which evaluates biosimilars for the EU, says "the evidence acquired over ten years of clinical experience shows that biosimilars approved through EMA can be used as safely and effectively in all their approved indications as other biological medicines"... Full

 

Southeast Asian Countries Consider EU Joint Clinical Assessment Model

(7/13, Francesca Bruce, Pink Sheet) ...Countries from ASEAN, the Association of Southeast Asian Nations, are looking at how the EU joint clinical assessment (JCA) model, which was introduced under the Health Technology Assessment Regulation (HTA), "could potentially be adapted for their purposes," a European Commission official has told the Pink Sheet... Global Sub. Full

 

EU, Japan And US Pharmacopeias Test Prospective Harmonization With AstraZeneca's Tagrisso

(7/13, Vibha Sharma, Pink Sheet) ...Under the initiative, announced on July 13, the European Pharmacopoeia (Ph. Eur.), the Japanese Pharmacopoeia (JP) and the United States Pharmacopeia (USP) will jointly develop harmonized pharmacopeial documentary standards for osimertinib mesilate and osimertinib tablets from the outset, rather than retrospectively reconciling differences after separate monographs have already been established... Global Sub. Full

 

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