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Pharmaceutical
25 August 2026   Spanish drugmaker PharmaMar has announced that health authorities in Canada, Qatar and South Korea have approved Zepzelca (lurbinectedin) in combination with atezolizumab (Roche’s Tecentriq) for the maintenance treatment for adult patients with extensive-stage small cell lung cancer (ES-SCLC) whose disease has not progressed following first-line induction therapy with atezolizumab, carboplatin and etoposide.
Pharmaceutical
6 August 2026   There are "no discussions" ongoing between AstraZeneca and Bristol Myers Squibb over a potential deal, a senior source close to the matter told Reuters on Wednesday, quashing the prospect of a mooted mega merger between the drugmakers.


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Insights


Pharmaceutical
Good clinical practice (GCP) is the rulebook that governs how trials on human volunteers are designed, run, recorded and reported. Every sponsor, contract research organization (CRO) and investigator site works to it, and every regulator inspects against it. It rarely makes headlines, but when the text changes, the daily mechanics of drug development change with it.   4 September 2026
Pharmaceutical
In June 2018 a manufacturer of valsartan told European regulators that its active ingredient contained N-nitrosodimethylamine (NDMA), a probable human carcinogen. The source was Chinese API maker Zhejiang Huahai Pharmaceutical (SHA: 600521). Within weeks, generic versions of the blood pressure drug were being recalled across Europe and the USA, and regulators began asking whether the problem was confined to one molecule.   4 September 2026
Pharmaceutical
An Expert View from Ethan Smith, Director of Oncology, Norstella.   3 September 2026
Pharmaceutical
The US Food and Drug Administration (FDA) publishes almost every stage of its manufacturing enforcement process, from inspection outcomes to the letters themselves. The databases are free, searchable and updated continuously. Read together, they show an agency that keeps finding the same small set of faults, in places that do not always match assumptions.   3 September 2026

Pharmaceutical
Russia is experiencing a shortage of drugs for patients with hemophilia B. Currently the most complex situation is observed in the case of both plasma-derived and recombinant coagulation factor IX which is the main replacement therapy for these patients, reports The Pharma Letter’s local correspondent.   1 September 2026
Pharmaceutical
In February, the US Food and Drug Administration (FDA) issued draft guidance describing how developers of individualized therapies for ultra-rare genetic conditions can establish effectiveness when a randomized controlled trial is not feasible.   27 August 2026
Pharmaceutical
The US biotech major Amgen's UK Director for Value, Access and Policy tells The Pharma Letter that closing the gap between National Institute for Health and Care Excellence (NICE) recommendation and routine patient access, not further investment alone, will determine whether the government's life sciences ambitions are realized.   25 August 2026

Boardroom

Pharmaceutical
US targeted cardiometabolic therapeutics company Sparrow Pharmaceuticals has announced the appointment of George Eldridge as chief financial officer (CFO).   9 September 2026
Pharmaceutical
New Jersey, USA-based precision oncology company PMV Pharmaceuticals today announced the appointment of Philip Herman as chief commercial officer (CCO).   9 September 2026
Pharmaceutical
Symbiosis Pharmaceutical Services, a UK-based specialist aseptic fill-finish contract development and manufacturing organisation (CDMO) headquartered in Stirling, Scotland, has appointed Jos Vergeest as senior business development director.   7 September 2026
Pharmaceutical
Bend Bioscience has announced the appointments of Pavlos Pavlidis as president and Sandeep Patel as chief financial officer, strengthening the company’s executive leadership team as it continues to expand its capabilities, operations, and support for pharmaceutical innovators.   4 September 2026