Latest Pharma and Biotech News
Generics
5 June 2026 The US Supreme Court has handed a unanimous win to British drugmaker Hikma in a closely watched generics patent case brought by Irish biopharma Amarin.
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Biotechnology
Swiss pharma giant Roche has entered into an exclusive licensing and collaboration agreement with Nurix Therapeutics. 8 June 2026
Pharmaceutical
US pharma giant Pfizer presented detailed results from multiple Phase IIb studies of berobenatide (PF-3944), an investigational, potential first-in-class monthly GLP-1 receptor agonist (GLP-1 RA) peptide, during a late-breaking expert symposium at the 86th Scientific Sessions of the American Diabetes Association (ADA). 8 June 2026
Pharmaceutical
Danish pharma major Novo Nordisk announced new clinical data from the positive Phase II trial of investigational zenagamtide, also known as amycretin. Zenagamtide is the first of its class, being a unimolecular peptide agonist of GLP-1 and amylin receptors. 8 June 2026
Generics
Russian pharmaceutical company KhimRar Group is expanding its capacities for the production of active pharmaceutical ingredients (APIs) by 10 times up to 50 tons per year, reports The Pharma Letter’s local correspondent. 8 June 2026
Pharmaceutical
Among licensing news of note last week, US drug developer Agios Pharma struck a deal with South Korea’s Oscotec for the latter’s cevidoplenib, a potential treatment for immune thrombocytopenia. US major AbbVie won European Commission approval for its migraine drug Aquipta. Travere Therapeutics licensed rights to civorebrutinib from China’s Everest Medicines, and Alnylam Pharmaceuticals entered into an AI collaboration with Inceptive Nucleics worth a potential $2 billion. 7 June 2026
Pharmaceutical
Chiesi Global Rare Diseases, a unit of privately-held Italian drugmaker Chiesi, announced that the European Commission (EC) has approved Lojuxta (lomitapide) capsules for use in children 5 years of age and older with homozygous familial hypercholesterolemia (HoFH), for use alongside diet and other lipid-lowering treatments, including LDL-apheresis where available. 6 June 2026
Biotechnology
US microbiome therapeutics company Seres Therapeutics announced two transactions aimed at strengthening its financial position and extending its operating cash runway into the first quarter of 2027. 6 June 2026
Pharmaceutical
Japan’s largest drugmaker Takeda today announced that it has filed a revised earnings report which reflects the impact of the jury verdict in the Amitiza (lubiprostone) antitrust litigation in the USA on its consolidated financial statements for fiscal year 2025, which ended March 31, 2026. The firm’s shares dipped 1.8% to 10,580 yen on the news. 5 June 2026
Generics
Russia will have its own generic of one of the world’s most expensive drug against cystic fibrosis, as the Russian pharmaceutical company Amedart announced its plans launch a domestic analogue of Trikafta (elexacaftor/tezacaftor/ivacaftor), a drug from the American company Vertex Pharmaceuticals for the treatment of cystic fibrosis, reports The Pharma Letter’s local correspondent. 5 June 2026
Pharmaceutical
Patrick Branch, partner, Tokyo office head, LEK Consulting, provides an Expert View on how the USA's most-favored-nation pricing reshapes the Japan business case. 5 June 2026
Biotechnology
Japan’s Otsuka announced that Voyxact (sibeprenlimab-szsi) preserved kidney function compared to placebo over 12 months in adults with primary IgA nephropathy (IgAN) at risk for disease progression. 5 June 2026
Biotechnology
US biotech Biogen has received US Food and Drug Administration (FDA) Breakthrough Therapy designation for salanersen, its investigational antisense oligonucleotide for spinal muscular atrophy (SMA). 5 June 2026
Biotechnology
US pharma giant Pfizer has signed a license agreement with San Francisco-based Chai Discovery, giving its scientists access to the AI company’s drug discovery platform for biologics research. 5 June 2026
Biotechnology
US clinical-stage biotech Kairos Pharma, which is focused on innovative cancer therapeutics, has provided a mid-year update for 2026 and a look ahead to the rest of the year in a letter to shareholders from chief executive Dr John Yu. The firm’s shares rose 4.8% to $0.48 on the announcement. 5 June 2026
Biotechnology
UK privately-held AMR Bio has submitted written comments to the Presidential Advisory Council on Combating Antibiotic-Resistant Bacteria (PACCARB) ahead of the Council's 27th public meeting on June 16, 2026, contributing to the next iteration of the US National Action Plan on Combating Antibiotic-Resistant Bacteria (NAP-CARB). 5 June 2026
Generics
The US Supreme Court has handed a unanimous win to British drugmaker Hikma in a closely watched generics patent case brought by Irish biopharma Amarin. 5 June 2026
Biotechnology
US biotech Stipple Bio has signed a multi-target licensing agreement with Swiss life sciences supplier Lonza to support development of next-generation antibody-drug conjugates (ADCs), including its lead oncology candidate STP-100. 5 June 2026
Biotechnology
Parabilis Medicines announced today that it plans to raise up to $475 million through a US initial public offering. The biopharmaceutical company filed to offer 25 million shares priced between $17 and $19 each. 5 June 2026
Pharmaceutical
US antivirals specialist Gilead Sciences applauds the leadership of the Government of South Africa and the Global Fund for accelerating access to lenacapavir, a long-acting HIV prevention medication. This marks an important step toward expanding access to lenacapavir for communities most affected by HIV. 5 June 2026
Pharmaceutical
The 2026 American Society of Clinical Oncology (ASCO) annual meeting delivered several potentially practice-changing datasets across solid tumors and hematologic malignancies, while underlining the growing influence of Chinese biotech innovation, antibody-drug conjugates and next-generation targeted therapies. 4 June 2026
All news
Pharmaceutical
Indian drugmaker Wockhardt (BOM: 532300) has secured a major regulatory breakthrough with the Central Drugs Standard Control Organization (CDSCO) granting approval for the import and marketing of its indigenously discovered antibiotic Zaynich in India. 1 June 2026
Pharmaceutical
Fewer new innovative medicines, and in fact with a delay of almost two years from their approval by the European Medicines Agency (EMA), are coming to Greece, as demonstrated by the Association of Pharmaceutical Companies of Greece (SFEE) in a press conference held to present two studies concerning Greek patients' access to new, innovative treatments. 1 June 2026
Pharmaceutical
Among news of note last week, Eli Lilly impressed with early-stage data for its investigational cholesterol treatment VERVE-102. The US pharma giant also continued its M&A spending spree, announcing the acquisitions of Curevo, LimmaTech and Vaccine Company for a total of around $3.8 billion. US antiviral specialist Gilead Sciences gained US Food and Drug Administration (FDA) approval for its hepatitis delta virus candidate Hepcludex. Pfizer entered into a cancer related licensing deal with Innovent, which could earn the Chinese company around $10 billion. 31 May 2026
Biotechnology
US biopharma company Mineralys Therapeutics, which is focused on developing medicines to target hypertension and related comorbidities such as chronic kidney disease (CKD), obstructive sleep apnea (OSA) and other diseases driven by dysregulated aldosterone, today presented new clinical data for lorundrostat at the 35th European Meeting on Hypertension and Cardiovascular Protection (ESH 2026) in Gdańsk, Poland. 30 May 2026
Biotechnology
Swiss drug developer Oculis Holding announced top-line results from its Phase III DIAMOND-1 and DIAMOND-2 trials of OCS-01 eye drops in patients with diabetic macular edema (DME), which disappointed, sending the firm’s shares tumbling 32% to $15.40 in after-market trading on Friday. 30 May 2026
Biotechnology
US biotech Capricor Therapeutics just named Michael Maurer as Chief Commercial Officer as the company heads toward an August 22 PDUFA date for deramiocel, its cell therapy for Duchenne muscular dystrophy. 30 May 2026
Pharmaceutical
US pharma major Bristol Myers Squibb shared data at the American Society of Clinical Oncology (ASCO) annual meeting Friday that demonstrated its CELMoD candidate mezigdomide more than doubled progression-free survival in patients with relapsed or refractory multiple myeloma. 29 May 2026
Biotechnology
UK pharma major AstraZeneca today disclosed that the global CARES Phase III clinical program showed that treatment with anselamimab, a potential first-in-class anti-fibril therapy, resulted in nominally statistically significant and highly clinically meaningful benefit in adults with advanced kappa light chain (AL) amyloidosis as first-line therapy added to standard of care plasma cell dyscrasia (PCD) treatments, compared to placebo. 29 May 2026
Pharmaceutical
US pharma giant Merck & Co, known as MSD outside of the USA and Canada, announced that calderasib (MK-1084), an investigational oral specific KRAS G12C inhibitor, in combination with Keytruda (pembrolizumab), Merck’s anti-PD-1 therapy, has been granted Breakthrough Therapy designation by the US Food and Drug Administration (FDA). 29 May 2026
Pharmaceutical
Beren Therapeutics announced that the US Food and Drug Administration (FDA) has extended by three months the review timeline of its New Drug Application (NDA) for adrabetadex for the treatment of infantile-onset Niemann-Pick disease, type C (I-NPC). 29 May 2026
Biosimilars
South Korean biosimilar specialist Samsung Bioepis announced the launch of Opuviz 40mg/mL solution for injection in a vial, a biosimilar referencing eye diseases drug Eylea (aflibercept), across Europe, starting today. 29 May 2026
Biotechnology
UK-based Accord Healthcare has won a National Institute for Health and Care Excellence recommendation for Hetronifly (serplulimab) in untreated extensive-stage small cell lung cancer, opening routine NHS access in England and Wales for a disease where progress has been stubbornly slow. 29 May 2026
Pharmaceutical
US pharma major Pfizer is paying $650 million upfront to partner with Chinese biotech Innovent on a broad slate of early-stage cancer medicines, in another sign of Western drugmakers leaning into China’s fast-moving research base. 29 May 2026
Biotechnology
AstraZeneca’s Imfinzi (durvalumab) in combination with Bacillus Calmette-Guérin (BCG) induction and maintenance therapy has been approved in the USA for the treatment of adult patients with BCG-naïve, high-risk non-muscle-invasive bladder cancer (NMIBC). 29 May 2026
Generics
The US Food and Drug Administration (FDA) yesterday published two final guidances for industry related to establishing bioequivalence. 29 May 2026
Pharmaceutical
The Pharmaceutical Research and Manufacturers of America has used National Cancer Research Month to argue that US cancer research leadership could weaken if pricing and reimbursement policies reduce incentives for drug development. 29 May 2026
Pharmaceutical
French health company Opella’s liver health brand Essentiale has launched a new healthcare professional education initiative designed to improve earlier recognition and treatment of metabolic dysfunction-associated steatotic liver disease (MASLD), formerly known as fatty liver disease. 29 May 2026
Biotechnology
GSK today announced that NICE has issued draft final guidance recommending Nucala (mepolizumab) for use on the National Health Service (NHS), as an add-on maintenance treatment option for adult patients with uncontrolled COPD. 28 May 2026
Biotechnology
Rhapsido (remibrutinib) is approved to treat chronic spontaneous urticaria (CSU). CSU affects the skin and is thought to be an autoimmune disease (when the immune system mistakenly attacks the body’s own cells, tissues and organs), Australia’s Therapeutic Goods Administration (TGA) announced today. 28 May 2026
Pharmaceutical
US pharma major Eli Lilly today announced an access milestone in obesity care: all three of the nation's largest pharmacy benefit managers (PBMs) will cover Lilly's full obesity medicine portfolio. 28 May 2026
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