‘Synchronized Swimming’ Must Wait, But FDA And EMA Ready To Collaborate On Botanical Drug Regulation
FDA and EMA say they could start collaboration on herbal and botanical drug regulation with batch-to-batch quality variation and herb-drug interactions. Industry sees adopting real-world evidence as key, but says harmonizing the two very different regulatory regimes is a long way off.
HBW Insight - October 28, 2026

Cipla Reiterates $1bn FY27 US Guidance Despite Lanreotide Woes As Ipsen Extends Gains
Cipla’s lanreotide supply disruption is seen continuing through FY27 as Pharmathen’s Greece unit is still on FDA’s October import alert list, but Cipla has reiterated a $1bn US sales guidance on the back of planned respiratory and peptide product launches.
Generics Bulletin - October 28, 2026

Bio-Thera Announces Chinese Approval For The First Secukinumab Biosimilar
Chinese regulator, the National Medical Products Administration (NMPA) has granted marketing approval for Bio-Thera's BAT2306, the first secukinumab biosimilar to be approved by any regulator worldwide, the company said.
Generics Bulletin - October 28, 2026

Celltrion Secures Major US Deals For Xolair Biosimilar Weeks After Launch
Celltrion’s youngest US commercial biosimilar Omlyclo (omalizumab-igec) has already secured deals within weeks of its launch, with other young products continuing to drive the firm’s financial performance.
Generics Bulletin - October 28, 2026

Locked Out? How Countries That Are Slow To Adopt Biosimilar Streamlining May Miss Out On Savings
At last week’s biosimilars webinar hosted by the IGBA, Robert Russell-Pavier of Medicines UK spoke about how countries that do not follow the trend of biosimilar streamlining could lose out on savings – and how the UK is both driving uptake but also risking making itself unattractive via low prices.
Generics Bulletin - October 28, 2026

Mankind’s Growth Strategy Puts Chronic Drugs, Specialty Portfolio In Focus
Mankind’s 50% chronic-therapy ambition sets direction for how it plans to reshape its domestic business.
Generics Bulletin - October 28, 2026

Nucleai’s ‘Tissue Intelligence’ Transforms ADC Drug Trials
Nucleai’s AI maps cells in pathology slides to explain why ADCs fail some patients, aiming to predict responders before trials, with Gilead its named partner.
In Vivo - October 28, 2026

ESMO 2026: Ris-Rez Offers First Progress In Osteosarcoma For Decades
A Phase III trial of GSK and Hansoh's risvutatug rezetecan delivered a 67% reduction in the risk of disease progression or death, demonstrating the benefits of the B7-H3-directed antibody-drug conjugate in relapsed osteosarcoma.
Scrip - October 28, 2026

APAC Recap: Asia Drafts AI Device Criteria, India Bans Device Reuse And Markups Draw Scrutiny
China, Japan and Korea issued AI device documents, Australia applied device rules to AI scribes, and Singapore widened reliance but left devices out of its HTA fast lane. India moved against hospital consumable markups and banned reuse of single-use devices.
Medtech Insight - October 28, 2026

ESMO 2026: Henlius Builds US SCLC Franchise On Solid Tecentriq Comparator Results
Supported by numerical superiority over Roche’s Tecentriq from a US-based bridging study, Henlius's serplulimab will help the Chinese firm build out a franchise in small cell lung cancer in the US and beyond.
Scrip - October 28, 2026

Nanexa’s Atomic Shell Game: How ALD Tech Landed A Novo Deal Worth Up To €1.165bn
Nanexa’s CEO said PharmaShell’s ALD-coated particles could stretch GLP-1 dosing to monthly or quarterly, but its semaglutide data are rat-based and simulated. Novo’s license, worth up to €1.165bn, and a Forge Nano scale-up deal frame what comes next, including combination-product questions.
Medtech Insight - October 28, 2026

ESMO 2026: Hengrui ADC Meets PFS Endpoints In HER2-Low Breast Cancer
Jiangsu Hengrui’s anti-HER2 ADC trastuzumab rezetecan reduced the risk of disease progression by 73% in a China-only Phase III trial in HER2-low metastatic breast cancer.
Scrip - October 28, 2026

GMP Violations Snag Rohto Eye Drop Plant In Vietnam, OTC Biologics Sales Trip Malaysian Firm
Japanese firm Rohto Pharmaceutical warned about GMP deficiencies at its plant in Ho Chi Minh, Vietnam, which led to recall started in July of all lots of its Rohto brand. FDA’s CBER warned Beaute Bounty in Kuala Lumpur after reviews of its website determined it was selling unlicensed biological prod
HBW Insight - October 28, 2026

Samsung Biologics Strike Threat Puts Client Confidence In Focus
Major global CDMO Samsung Biologics and labor union set to open new new talks designed to resolve pay dispute.
Scrip - October 28, 2026

Biobeat Says Chest Patch Could Provide Alternative To Cuff-Based BP Monitoring
Biobeat says interim data from its 600-patient trial support its FDA-cleared chest patch as a more comfortable alternative to cuff-based 24-hour blood pressure monitoring. The 2025 AHA/ACC hypertension guideline still advises against cuffless devices for diagnosis.
Medtech Insight - October 28, 2026