10 October 2024 Machine learning-enabled drug discovery and development company insitro has announced the execution of three strategic agreements with Eli Lilly.
Danish dermatology specialist Leo Pharma has revealed plans to cut 200 jobs, marking the company’s fourth workforce reduction since 2022. 11 October 2024
Booster Therapeutics, a biotechnology company pioneering a new class of proteasome activator medicines to treat neurodegenerative and other diseases, has launched with the support of a $15 million financing. 11 October 2024
German cancer specialist Immatics has announced the pricing of its $150 million public offering, with Jefferies, BofA Securities, and Leerink acting as joint book runners. 11 October 2024
The UK's Medicines and Healthcare products Regulatory Agency (MHRA) has approved Pfizer and BioNTech's latest COVID-19 vaccine, Comirnaty (KP.2). 11 October 2024
In what Astella Pharma calls “a landmark decision for advanced bladder cancer patients,” the Japanese drugmaker gained approval in the UK for its treatment regimen. 10 October 2024
Nanoscope Therapeutics says that, following a productive FDA meeting with the US Food and Drug Administration (FDA) for its clinical program evaluating MCO-010 for the treatment of retinitis pigmentosa (RP), the company will commence with submission of a Biologics License Application (BLA) in the first quarter of 2025. 10 October 2024
US healthcare giant Johnson & Johnson’s Tecvayli (teclistamab) has been recommended by the National Institute for Health and Care Excellence (NICE) as a first-line option to treat myeloma in England and Wales. 10 October 2024
China’s Quantum Pharmaceuticals has announced a significant licensing agreement between its biologics-focused subsidiary, Ailux Biologics, and Johnson & Johnson. 10 October 2024
USA-based Kezar Life Sciences announced this week that it was pausing its Phase IIb PALIZADE trial evaluating zetomipzomib in lupus nephritis (LN) following the deaths of four patients. 10 October 2024
Advances in gene editing, such as the FDA approval of Vertex Pharmaceuticals’ Casgevy (exagamglogene autotemcel) in December 2023 for the treatment of beta thalassemia and sickle cell disease, have fueled significant interest in innovative epigenetic drugs. 10 October 2024
Gene therapy start-up GEMMA Biotherapeutics (GEMMABio) has announced a significant partnership with Brazil's Fiocruz, a key supplier for the Brazilian Ministry of Health. 10 October 2024
California’s Arda Therapeutics, a biotech focused on targeted cell depletion therapies for chronic diseases, has announced the successful completion of a $43 million Series A financing round. 9 October 2024
Purespring Therapeutics, a gene therapy company focused on transforming the treatment of kidney diseases, has raised £80 million ($105 million) in a Series B financing. 9 October 2024
German family-owned pharma major Boehringer Ingelheim and USA-based Circle Pharma (have entered into a research collaboration and license agreement with the shared goal to develop a first-in-class cyclin inhibitor that can halt the growth of cancer cells potentially offering hope to those living with hard-to-treat cancers. 9 October 2024
The VIALE-C (M16-043) trial of Venclexta (venetoclax) in combination with low-dose cytarabine (LDAC) versus LDAC in combination with placebo did not meet its primary endpoint of statistically-significant improvement of overall survival (OS) for patients with acute myeloid leukemia (AML) who are ineligible for intensive chemotherapy at the time of the planned analysis. 29 February 2020
Biohaven Pharmaceutical Holding late Thursday gained regulatory approval for its migraine treatment drug to join the already competitive market sector, with the news sending its shares up 5.3% to $40.82 in after-hours trading, after falling 8.5% in the regular session. 28 February 2020
After the bell on Thursday US biotech major Biogen and genomic medicines company Sangamo Therapeutics announced that they have executed a global licensing collaboration agreement, that could be worth over $2.5 billion, with the news sending the latter’s shares almost 40% higher to $9.31 in after-hours trading. 28 February 2020
Data on Vitrakvi (larotrectinib) in adult and pediatric patients with TRK fusion cancer shows the need to identify suitable patients through genomic testing, says German pharma major Bayer. 27 February 2020
Germany’s Boehringer Ingelheim and privately-held US firm Trutino Biosciences have entered into a research collaboration and worldwide licensing agreement based on Trutino’s innovative On-Demand-Cytokine (ODC) platform. 27 February 2020
Singapore-based Tessa Therapeutics, a Temasek-backed clinical stage biotech company, has been granted Regenerative Medicine Advanced Therapy (RMAT) designation for its experimental CD30-directed autologous Car-T cell candidate. 27 February 2020
A vote of the US Food and Drug Administration’s (FDA) Oncologic Drugs Advisory Committee (ODAC) on Eli Lilly’s Cymramza (ramucirumab) has narrowly come out in favor of using the drug in combination with erlotinib in a lung cancer indication. 27 February 2020
The Brazilian Health Regulatory Agency (ANVISA) has approved Onpattro (patisiran) for the treatment of hereditary transthyretin-mediated (hATTR) amyloidosis in adults with stage 1 or stage 2 polyneuropathy. 27 February 2020
The US Food and Drug Administration has approved a supplemental New Drug Application (sNDA) for Nerlynx (neratinib) in combination with capecitabine for the treatment of adult patients with advanced or metastatic HER2-positive breast cancer who have received two or more prior anti-HER2-based regimens in the metastatic setting. 27 February 2020
The Institute for Clinical and Economic Review (ICER) today released a Final Evidence Report and Report-at-a-Glance assessing the comparative clinical effectiveness and economic value of three acute treatments for migraine. 26 February 2020
Under a January 2017 agreement, Japanese drug major Takeda Pharmaceutical has now taken up its option to acquire PvP Biologics, following the conclusion of a Phase I proof-of-mechanism study of investigational medicine TAK-062 (Kuma062) for the treatment of uncontrolled celiac disease. 26 February 2020
With stocks reeling over safety concerns for blindness medicine Beovu (brolucizumab), Swiss pharma giant Novartis has begun an external review into the product. 26 February 2020
US biotech Vertex Pharmaceuticals (Nasdaq: VRTX) today announced that Kalydeco (ivacaftor) will be available to eligible patients with cystic fibrosis (CF) in New Zealand from March 1. 26 February 2020
A randomized, controlled clinical trial to evaluate the safety and efficacy of the investigational antiviral remdesivir in hospitalized adults diagnosed with coronavirus disease 2019 (COVID-19) has begun at the University of Nebraska Medical Center (UNMC) in Omaha. 26 February 2020
UK-based biotech Bicycle Therapeutics has entered into a strategic collaboration agreement with Swiss pharma giant Roche’s Genentech subsidiary, a to discover, develop and commercialize novel Bicycle-based immuno-oncology (I-O) therapies. 25 February 2020
US biotech NGM Biopharmaceuticals yesterday announced positive preliminary top-line results for its liver disease candidate aldafermin, sending the firm’s shares rocketing 23.5% to $20.00 in heavy volume by Monday mid-morning, having jumped as much as 41%. 25 February 2020
The US Food and Drug Administration has granted priority review for the supplemental New Drug Application (sNDA) to expand the use of Alunbrig (brigatinib) as a first-line treatment for patients with anaplastic lymphoma kinase-positive (ALK+) metastatic non-small cell lung cancer (NSCLC) as detected by an FDA-approved test. 25 February 2020
The US Food and Drug Administration (FDA) and European Medicines Agency (EMA) have accepted the supplemental Biologics License Application (sBLA) and Marketing Authorization Application (MAA), respectively, for ofatumumab (OMB157) for the treatment of relapsing forms of multiple sclerosis (RMS) in adults. 24 February 2020