Pharma Now

Cipla's agreement with Qilu Pharmaceutical positions the Indian generics major directly in the pembrolizumab biosimilar race, a corridor where US biosimilar approval pathways and interchangeability designations will determine commercial viability as Merck's Keytruda patent estate begins to open. Under the partnership, Qilu supplies the biosimilar candidate while Cipla holds responsibility for US commercialisation.

Regulatory affairs teams managing multi-program dossiers now have a live benchmark to measure against: Weave Bio has deployed its AI-driven regulatory submission platform across 14 of Takeda's drug programs, targeting the submission workflows that consistently consume the most calendar time in large-portfolio development cycles.

Teva Pharmaceutical Industries' return to full investment-grade standing across all three major credit agencies opens a narrower but meaningful corridor for capital allocation decisions that plant heads and supply-chain leads will feel in coming budget cycles. S&P Global Ratings upgraded Teva's long-term issuer credit rating to BBB- from BB+ on September 4, 2026, with a Stable outlook, completing a trifecta that includes recent upgrades from Fitch and Moody's.

A single-site dependency on a US-based active substance manufacturer drove the EU's Visudyne (verteporfin) shortage into a controlled distribution regime, and the regulatory pathway used to exit that regime now offers plant heads and QA directors a concrete template for supply chain vulnerability planning.

A positive Phase III readout from the SANOVO trial positions AstraZeneca and HUTCHMED's Tagrisso-Orpathys combination as a credible first-line standard of care for EGFR-mutated non-small cell lung cancer in China, with label expansion filings and manufacturing scale-up decisions likely to follow in close sequence. The SANOVO data reinforce Tagrisso's role as a backbone therapy in the EGFR-mutated NSCLC setting.

A formal referral procedure now under way at EMA's Pharmacovigilance Risk Assessment Committee (PRAC) puts manufacturers of injectable iron-containing medicines on notice: existing risk minimisation measures for hypophosphataemia and hypophosphataemic osteomalacia may be insufficient, and marketing authorisation changes could follow. Regulatory affairs and QA teams at affected sites should treat this as an active signal, not a background review.

Intrathecal antisense oligonucleotide manufacturing just acquired a commercial-scale reference point: Ion's Zanvastro (zilganersen) received FDA approval on September 3, 2026, becoming the first approved therapy for Alexander disease across pediatric and adult patients. For CDMOs and sterile injectables manufacturers already building ASO capabilities, the approval establishes a validated intrathecal delivery model for a rare neurological indication.

MUMBAI, INDIA — Following the success of its inaugural edition, Mumbai Biocluster, a Section-8 not-for-profit institution under the Institute of Chemical Technology (ICT), Mumbai, has announced the second edition of the Peptides & Complex Generics Symposium (PCG 2026). The symposium will take place on 28–29 September 2026 at Aurika by Lemon Tree Hotels, Mumbai.

CBER's consolidated industry resource page positions itself as the primary navigation point for biologics manufacturers managing BLA submissions, postmarketing compliance, and GMP obligations under 21 CFR 600–680, a reference set that QA directors and regulatory affairs leads should have mapped against their internal SOPs. The page aggregates the regulatory framework governing biological products under the Public Health Service Act and the Federal Food, Drug, and Cosmetic Act, covering the...

Tarsus Pharmaceuticals has closed its acquisition of Alkeus Pharmaceuticals, bringing a late-stage orphan asset carrying four FDA designations into a portfolio that will now require supply chain, manufacturing, and regulatory infrastructure scaled for a rare pediatric indication with no approved comparator. For plant heads and QA directors, the transaction signals an accelerating pipeline obligation tied to the global NORTHSTAR Phase 3 trial, with topline data not expected until 2029.