Regulation
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Generics
Taiwanese generics and biosimilar drugmaker Lotus Pharmaceutical has received approval for its abbreviated new drug application (ANDA) in the Philippines for its generic versions of Bristol Myers Squibb’s Revlimid (lenalidomide) and AstraZeneca’s lung cancer drug Iressa (gefitinib). 2 March 2022
Pharmaceutical
The US medicines regulator has issued three final guidances to drugmakers regarding cancer clinical trials, reflecting a broader push from the administration to improve healthcare outcomes in oncology. 2 March 2022
Pharmaceutical
Japan-headquartered ophthalmology specialist Santen Pharmaceutical has received approval for the transfer of the Marketing Authorization of the rho kinase inhibitors (ROCK inhibitors) Rhokiinsa (netarsudil 200mcg/ml eye drops, solution) and Roclanda (latanoprost 50mcg/ml and netarsudil 200mcg/ml eye drops, solution) in the European Economic Area (EEA) from the European Medicines Agency (EMA) and in the UK from the Medicines and Healthcare products Regulatory Agency (MHRA). 2 March 2022
Biotechnology
Gilead Sciences has been issued with a complete response letter (CRL) from the US Food and Drug Administration for lenacapavir, an investigational HIV med. 1 March 2022
Biotechnology
Legend Biotech, a clinical stage CAR-T immuno-oncology biotech spun out of Hong Kong-listed GenScript Biotech, says that the US Food and Drug Administration has approved its first product, Carvykti (ciltacabtagene autoleucel; cilta-cel). 1 March 2022
Biotechnology
Shares of Ireland-headquartered rare diseased biotech Amryt Pharma fell as much as 31% yesterday, after it announced the receipt of a Complete Response Letter (CRL) from the US Food and Drug Administration regarding its New Drug Application (NDA) for Oleogel-S10. 1 March 2022
Pharmaceutical
In a European worksharing procedure (WSP), Germany’s Merck KGaA Glucophage (metformin hydrochloride) and its immediate and extended release versions have been approved as the first oral anti-diabetic medication to be used safely during pregnancy. 28 February 2022
Biotechnology
South Korea’s GC Pharma saw its shares fall 6.2% to 182,000 won, after it revealed it has received a Complete Response Letter (CRL) from the US Food and Drug Administration in response to its Biologics License Application (BLA) for Alyglo (immune globulin intravenous (human), 10% liquid). 28 February 2022
Biosimilars
The US Food and Drug Administration (FDA) has accepted for review the Prior Approval Supplement (PAS) to the Biologics License Application (BLA) submitted by pharma giant Pfizer for Abrilada (adalimumab-afzb) as an interchangeable biosimilar to Humira (adalimumab). 26 February 2022
Biotechnology
The US Food and Drug Administration on Friday issued a Complete Response Letter (CRL) regarding the New Drug Application (NDA) for bardoxolone methyl for the treatment of patients with chronic kidney disease (CKD) caused by Alport syndrome, said the drug’s developer, Reata Pharmaceuticals, whose shares fell 3.7% to $25.16 in after-hours trading. 26 February 2022
Pharmaceutical
Following its February meetings, the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has recommended approval for six novel new medicines, as well as two biosimilars. 25 February 2022
Biotechnology
Canadian biopharma company Medicago and UK pharma major GlaxoSmithKline have announced that Health Canada has granted approval for Covifenz, COVID-19 vaccine, (plant-based virus-like particles [VLP], recombinant, adjuvanted). 25 February 2022
Biotechnology
Rare diseases specialist Swedish Orphan Biovitrum, also known as Sobi, today announced that the Center for Drug Evaluation (CDE) has recommended approval of Gamifant (emapalumab) to the National Medical Products Administration of China (NMPA). 25 February 2022
Pharmaceutical
The first home-grown coronavirus pill in Japan has been submitted to the medicines regulator for early approval. 25 February 2022
Pharmaceutical
A new broader label for heart med Jardiance (empagliflozin) will help developers Eli Lilly and Boehringer Ingelheim extend the increasingly lucrative franchise. 25 February 2022
Biotechnology
The European Medicines Agency’s human medicines committee (CHMP) has recommended granting an extension of indication for Spikevax (COVID-19 Vaccine, mRNA) to include use in children aged six to 11. 24 February 2022
Pharmaceutical
Research from industry analyst GlobalData shows that USA-based cardiorenal specialist Ardelyx has the potential to make significant inroads with its candidate tenapanor. 24 February 2022
Pharmaceutical
The US Food and Drug Administration has granted Breakthrough Therapy designation to the novel investigational therapy, BI 1015550, for the treatment of idiopathic pulmonary fibrosis (IPF), under development by family-owned German drug major Boehringer Ingelheim. 24 February 2022
Pharmaceutical
Indian vaccine maker Biological E Limited (BE) has announced that its Corbevax vaccine, which is India's first indigenously developed receptor binding domain (RBD) protein sub-unit vaccine against COVID-19, has received emergency use authorization (EUA) from India's drug regulator for the 12 to 18-year age group. 24 February 2022
Pharmaceutical
Rare Disease Day is celebrated every year on February 28th. This year, the theme “share your colors” is a call to raise awareness for the over 7,000 rare diseases known to science, with focus on drug development, improved access to care, equity, and policy-making. In this article, we will dive into the latest research and drug development for a few select rare diseases (Duchenne muscular dystrophy and SCN8A), as well as examine the latest in policy-making by governments and non-governmental organizations across the world. 24 February 2022
Pharmaceutical
Shanghai-based Dizal has made a submission to the US Food and Drug Administration, seeking approval for sunvozertinib. 8 November 2024
Biotechnology
US mRNA specialist Moderna today announced Health Canada has approved mRESVIA (respiratory syncytial virus mRNA vaccine) for active immunization for the prevention of lower respiratory tract disease caused by respiratory syncytial virus (RSV) in adults 60 years of age and older. 8 November 2024
Biotechnology
US healthcare giant Johnson & Johnson today revealed it has submitted applications with the US Food and drug Administration (FDA) and European Medicines Agency (EMA) to expand the approved indications for its Darzalex (daratumumab) subcutaneous (SC) formulation for the treatment of high-risk smouldering multiple myeloma (SMM). 8 November 2024
Biotechnology
Asklepios BioPharmaceutical (AskBio) today announced that AB-1003 (also known as LION-101) has received rare pediatric disease designation and orphan-drug designation from the US Food and Drug Administration (FDA) for the treatment of limb-girdle muscular dystrophy type 2I/R9 (LGMD2I/R9). 7 November 2024
Pharmaceutical
USA-based Acadia Pharmaceuticals has entered into a definitive asset purchase agreement to sell its Rare Pediatric Disease Priority Review Voucher (PRV) for $150 million upon the closing of the transaction. 6 November 2024
Biotechnology
GSK’s Arexvy (RSV vaccine) has received an expanded approval in Canada to prevent lower respiratory tract disease (LRTD) caused by respiratory syncytial virus (RSV) in adults aged 50-59 who are at increased risk. 6 November 2024
Biotechnology
French pharma major Sanofi’s Dupixent (dupilumab), which notched up sales of 3.5 billion euros ($3.8 billion) in third-quarter 2024, +23.8% year-on-year, has picked up yet another indication in collaboration with Regeneron. 6 November 2024
article
The US Food and Drug Administration (FDA) has announced approval of a modification to the Opioid Analgesic Risk Evaluation and Mitigation Strategy (OA REMS) 6 November 2024
Pharmaceutical
European regulators will decide by December 6 whether Novo Holdings, the controlling shareholder of Danish pharma giant Novo Nordisk, can finalize its $16.5 billion acquisition of contract drug manufacturer Catalent. 5 November 2024
Pharmaceutical
Photocure, a Norway-based bladder cancer-focused company, has announced that Jiangsu Yahong Meditech, the parent company of its partner Asieris Pharmaceuticals, has received marketing authorization for Hexvix (hexaminolevulinate) in China. 5 November 2024
Pharmaceutical
The US Food and Drug Administration (FDA) has accepted for review the New Drug Application (NDA) for donidalorsen, an investigational RNA-targeted medicine for prophylaxis to prevent attacks of hereditary angioedema (HAE) in adult and pediatric patients 12 years of age and older, under development by Ionis Pharmaceuticals. 4 November 2024
Pharmaceutical
Disc Medicine today announced a successful End of Phase 2 with the US Food and Drug Administration (FDA) supporting the regulatory path forward, including potential for accelerated approval, for bitopertin in erythropoietic protoporphyria (EPP). 4 November 2024
Pharmaceutical
On Friday, the US Food and Drug Administration published the FDA Voices: “FDA Takes Exciting Steps Toward Establishing the Rare Disease Innovation Hub,” by Patrizia Cavazzoni, director of the FDA’s Center for Drug Evaluation and Research (CDER) and Dr Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research (CBER). 4 November 2024
Biotechnology
The US Food and Drug Administration (FDA) has granted a Rare Pediatric disease designation for BPM31510T, an investigational treatment for epidermolysis (EB) from BPGbio. 4 November 2024
Pharmaceutical
US pharma major AbbVie last week proposed $1.4 billion acquisition of US CNS drug developer Aliada Therapeutics. Last week saw a bunch of third quarter 2024 financials results, among which were Elil Lilly, AbbVie and Merck & Co. Also of note, Lexicon’s type I diabetes drug Zynquista faced a Food and Drug Administration (FDA) advisory committee review that resulted in largely negative vote against recommendation. 3 November 2024
Pharmaceutical
Texas-based biopharma Lexicon Pharmaceuticals was trading nearly 36% lower on Friday morning. 1 November 2024
Generics
Medicines for Europe has launched a study of market barriers faced by European generics and biosimilar pharmaceutical companies operating in 11 key third-country markets. 31 October 2024
Biotechnology
The UK Medicines and Healthcare products Regulatory Agency (MHRA) has approved the medicine sugemalimab (trade name Eqjubi) to treat adult patients with a type of cancer called non-small cell lung cancer (NSCLC ). 31 October 2024
Pharmaceutical
Novartis late yesterday revealed that Scemblix (asciminib) was granted accelerated approval by the US Food and Drug Administration (FDA) for adult patients with newly diagnosed Philadelphia chromosome-positive chronic myeloid leukemia in chronic phase (Ph+ CML-CP). 30 October 2024
Pharmaceutical
Privately-held US drugmaker Protega Pharmaceuticals says that the US Food and Drug Administration (FDA) has approved Roxybond (oxycodone hydrochloride) immediate-release (IR) CII 10mg tablet for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. 29 October 2024
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