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French biotech OSE Immunotherapeutics is accelerating a strategic reset, pausing development of OSE-230 and discontinuing certain early research programs to concentrate capital and management bandwidth on its two late-stage assets, Tedopi (osepepitimut-S) and lusvertikimab (OSE-127). 3 March 2026
Pharmaceutical
Progressive pulmonary fibrosis (PPF) represents one of the most challenging phenotypes within the interstitial lung disease (ILD) space and is defined by worsening fibrosis observed by high-resolution computed tomography scans, declining lung function, and persistent symptoms. 2 March 2026
Biotechnology
February 2026 delivered significant signals across the rare disease ecosystem, spanning regulatory approvals, legislative incentives, clinical trial outcomes, emerging designations, and safety reviews. Below is a summary of the most impactful developments. 2 March 2026
Pharmaceutical
Regulatory news last week included US drugmaker Vanda Pharmaceuticals gaining Food and Drug Administration (FDA) approval for its schizophrenia drug candidate Bysanti, and Germany’s Boehringer Ingelheim winning FDA clearance for its kinase inhibitor Hernexeos for the treatment of lung cancer. On the M&A front, Gilead Sciences revealed an up to $7.8 billion plan to acquire Arcellx. Also of note, Protara Therapeutics released new Phase II data on its investigational blood cancer drug TARA-002. 1 March 2026
Pharmaceutical
The European Medicines Agency’s (EMA) human medicines committee (CHMP) recommended 6 novel medicines for approval at its February 2026 meeting. These now have to be approved by the European Commission, which usually takes two months or so. 27 February 2026
Pharmaceutical
The US Food and Drug Administration (FDA) has granted accelerated approval to Hernexeos (zongertinib), from German family owned Boehringer Ingelheim, a kinase inhibitor, for an expanded indication for adults with unresectable or metastatic non-squamous non-small cell lung cancer (NSCLC) whose tumors have HER2 (ERBB2) tyrosine kinase domain (TKD) activating mutations, as detected by an FDA-authorized test. 27 February 2026
Biotechnology
German family-owned pharma major Boehringer Ingelheim and UK clinical stage biotech Sitryx Therapeutics announced that Boehringer has acquired an exclusive license for a pre-clinical, small molecule program from Sitryx. 27 February 2026
Generics
In a major boost for India’s generics industry, the Delhi High Court has ruled that Macleods Pharmaceuticals may continue its petition to revoke a patent held by German drugmaker Boehringer Ingelheim, even though the patent has already expired. 26 February 2026
Biotechnology
At the 44th annual JP Morgan Healthcare conference, US biotech Insmed delivered one of the most closely watched updates in the respiratory space, detailing its clinical and commercial plans for 2026. 13 February 2026
Pharmaceutical
USA-based rare disease drug developer PTC Therapeutics saw its shares drop 5.2% to $67.05 after market close, when it announced that it has withdrawn the New Drug Application (NDA) resubmission for Translarna (ataluren) for the treatment of nonsense mutation Duchenne muscular dystrophy (DMD) following US Food and Drug Administration (FDA) feedback on the application review. 13 February 2026
Pharmaceutical
For the entire 2025 fiscal year, French drugmaker Ipsen’s revenues rose by 8.1%, or 10.9% at constant exchange rates, reaching a total of 3.68 billion euros ($4.37 billion). 12 February 2026
Pharmaceutical
German CDMO Rentschler Biopharma has appointed Veit Bergendahl as chief operating officer and a member of its executive board, effective from April. 11 February 2026
Pharmaceutical
The US Department of Health and Human Services (HHS) has issued new guidance clarifying when direct-to-consumer (DTC) drug sales are unlikely to breach the federal anti-kickback statute, as more biopharmas roll out cash-pay models and ahead of the planned TrumpRx portal launch. 29 January 2026
Pharmaceutical
German family-owned pharma major Boehringer Ingelheim today announced results from a Phase II trial evaluating apecotrep (BI 764198) as a novel, targeted, non-immunosuppressive therapy in people with primary focal segmental glomerulosclerosis (FSGS), a rare kidney condition. 28 January 2026
Biotechnology
Privately-held German drugmaker Boehringer Ingelheim has announced a license and collaboration agreement to develop SIM0709, a pre-clinical TL1A/IL23p19 bispecific antibody from China’s Simcere Pharmaceutical Group, for the treatment of inflammatory bowel disease (IBD). 27 January 2026
Pharmaceutical
French drugmaker Ipsen announced that the Arbitral Tribunal of the International Chamber of Commerce (ICC) has issued a final decision in favor of Ipsen, dismissing the claim initiated by Galderma in the arbitration proceedings related to Ipsen’s termination of the R&D agreement. 22 January 2026
Pharmaceutical
The US Food and Drug Administration (FDA) has granted Breakthrough Therapy designation (BTD) for French drugmaker Ipsen’s IPN60340 in combination with venetoclax and azacitidine (Ven-Aza) in first line unfit acute myeloid leukemia, an aggressive blood cancer affecting older adults. 14 January 2026
Pharmaceutical
Swiss biotech TECregen has raised 10 million Swiss francs ($12.6 million) in seed financing to advance its thymus regeneration platform, a niche but fast-growing area of immune medicine. The round was led by the Boehringer Ingelheim Venture Fund, with support from several European life sciences investors. 8 January 2026
Pharmaceutical
Chinese RNA drug developer Ribo has launched a Hong Kong IPO, positioning its lead siRNA candidate for thrombotic diseases as a flagship asset as investors gain rare access to China’s small nucleic acid drug sector. 5 January 2026
Biotechnology
Cambridge USA-based biotech Rectify Pharmaceuticals has entered a strategic research and licensing agreement with German family-owned pharma major Boehringer Ingelheim to accelerate the development of treatments for chronic kidney disease (CKD) and other conditions. 23 December 2025
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Pharmaceutical
I've worked with pharmaceutical companies for years, and one pattern keeps repeating: the most significant environmental, health, and safety (EHS) risks are rarely dramatic. They sit in routine practices, steadily increasing cost and exposure without drawing much attention. 5 March 2026
Pharmaceutical
Canada based clinical-stage pharma Helus Pharma today announced top-line results from a Phase II signal detection study evaluating HLP004 as a potential treatment for adults with moderate-to-severe generalized anxiety disorder (GAD) who remained symptomatic despite ongoing SoC antidepressant therapy, including selective serotonin reuptake inhibitors and related agents. 5 March 2026
Pharmaceutical
Swiss drugmaker Roche has released findings from a global survey suggesting that the unpredictability of diabetes continues to shape everyday life for many patients, limiting spontaneity and adding a persistent mental burden. 5 March 2026
Pharmaceutical
USA-based Biologos, an ISO 13485–certified and GMP-compliant manufacturer of custom sterile-filtered liquid solutions, today announced the appointment of Hetal Patel as chief executive. 5 March 2026
Pharmaceutical
Germany’s Merck KGaA reported broadly stable full-year 2025 results, with modest top-line pressure from currency headwinds but continued profitability, while investors focused on a softer outlook for 2026. 5 March 2026
Pharmaceutical
Medicus Pharma has announced top-line results from its Phase II study of doxorubicin microneedle array (D-MNA) to non-invasively treat basal cell carcinoma (BCC) of the skin. 5 March 2026
Pharmaceutical
French pharma Sanofi has agreed to license the experimental drug rovadicitinib from China’s Sino Biopharmaceutical, paying $135 million upfront for exclusive development and commercialization rights outside China. 5 March 2026
Pharmaceutical
Chinese biopharma Hutchmed today reported a net income of $456.9 million for the year ended December 31, 2025, a significant increase from $37.7 million in the prior year, largely driven by a $415.8 million divestment gain and profitable core operations. 5 March 2026
Biotechnology
Chinese cell therapy developer Lemang Biotech has raised nearly 200 million yuan ($28 million) in fresh financing to advance clinical development of its metabolism-enhanced CAR-T therapies and scale up manufacturing. 5 March 2026
Biotechnology
Shares of Hansa Biopharma rose nearly 7% to 32.98 kronor, after the Swedish company announced that the Food and Drug Administration (FDA) has notified the company that the previously accepted Biologics License Application (BLA) for imlifidase has been assigned a Prescription Drug User Fee Act (PDUFA) action date of December 19, 2026. 5 March 2026
Pharmaceutical
For more than 40 years, the USA has led the world in biopharmaceutical research, development and manufacturing, said the trade group Pharmaceutical Research and Manufacturers of America (PhRMA). 5 March 2026
Pharmaceutical
German family-owned pain medicines specialist Grünenthal has entered into collaboration with BCWorld Pharm for the exclusive South Korean rights to Qutenza (capsaicin), a topical, non-systemic, non-opioid patch treatment. In Europe, the product is indicated for the management of peripheral neuropathic pain. 5 March 2026
Biotechnology
US biotech Prolium Bioscience has announced its launch with a $50 million Series A financing to develop PRO-203, a potential best-in-class CD20xCD3 T-cell engager, for severe autoimmune disease. 4 March 2026
Pharmaceutical
Germany’s Bayer reported its financial results for the fourth quarter of 2025, along with the full year figures. 4 March 2026
Generics
India’s Glenmark Pharmaceuticals has received final approval by the US Food and Drug Administration for its fluticasone propionate inhalation aerosol USP, the first generic copy of GSK’s (LSE: GSK) Flovent to be authorized in the USA. 4 March 2026
Biotechnology
US biotechnology company Candid Therapeutics will go public through a reverse merger with US rare disease drugmaker Rallybio, creating a Nasdaq-listed company focused on T-cell engager therapies for autoimmune diseases. 4 March 2026
Pharmaceutical
US neuro-focused company NeuroOne has appointed David Wambeke as chief business officer, tasking him with leading the firm’s drug delivery program as it seeks partnerships around its neurological treatment platform. 4 March 2026
Pharmaceutical
US clinical-stage biotech Latigo Biotherapeutics has appointed Neha Krishnamohan as chief financial officer and chief business officer, adding a finance executive with experience across biotech capital markets and corporate strategy as the company advances its non-opioid pain pipeline. 4 March 2026
Pharmaceutical
Ireland-incorporated Theravance Biopharma has announced top-line results from the Phase III CYPRESS study of ampreloxetine in patients with symptomatic neurogenic orthostatic hypotension (nOH) due to multiple system atrophy (MSA), a rare disease. 4 March 2026
Pharmaceutical
Japanese drugmaker Ono Pharmaceutical has entered into an agreement to expand the drug discovery collaboration agreement with Canada’s Congruence Therapeutics for the discovery of novel small molecule modulators against multiple protein targets in the areas of neurology and immunology. 4 March 2026
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