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Biotechnology
The US Food and Drug Administration has given a green light to BrainStorm Cell Therapeutics for the design of a Phase IIIb trial of NurOwn (MSC-NTF cells). 10 April 2024
Pharmaceutical
Research suggests there will likely be strong uptake for the first USA-approved therapy for metabolic dysfunction-associated steatohepatitis (MASH). 9 April 2024
Pharmaceutical
The US regulator has once more rebuffed efforts on the part of Supernus Pharmaceuticals to register its Parkinson’s disease candidate SPN-830. 9 April 2024
Pharmaceutical
Of the 46 cancer drugs for which the US Food and Drug Administration (FDA) granted accelerated approval between 2013-2017, 63% were converted to regular approval even though only 43% demonstrated a clinical benefit in confirmatory trials after more than five years of follow-up, according to a study presented at the American Association for Cancer Research (AACR) 2024 annual meeting. 9 April 2024
Biotechnology
Two frequent words that people often hear in recent China’s pharma industry comments are “Chu Hai” and “Nei Juan”. The former means “selling overseas,” while the latter means “cut throat competition.” 8 April 2024
Pharmaceutical
Providing continuing competition to market leader Gilead Sciences, ViiV Healthcare has achieved a new milestone in the HIV space. 8 April 2024
Biotechnology
The US Food and Drug Administration (FDA) has approved Johnson & Johnson and Legend Biotech’s Carvykti (ciltacabtagene autoleucel) in a new indication. 8 April 2024
Biotechnology
After a previous delay last November, and a positive AdCom recommendation last month, the US Food and Drug Administration (FDA) has now approved an additional indication for Abecma (idecabtagene vicleucel; ide-cel). 8 April 2024
Pharmaceutical
Denmark’s Pharmaceutical Industry Association (Lif) says that the first quarter of 2024 will be remembered as the quarter with the highest number of non-recommendations since the Medical Council introduced the new method for assessments. 8 April 2024
Biotechnology
Among last week’s news, Switzerland-based Roivant Sciences and partner company Priovant released positive Phase II data for their uveitis candidate brepocitinib. On the M&A front, Danish drugmaker Genmab announced it would acquire privately-held USA-based ProfoundBio for $1.8 billion in cash, gaining access to its antibody-drug conjugate (ADC) Rina-S. Also, US healthcare giant Johnson & Johnson on Friday revealed its intention to acquire cardio-devices leader Shockwave Medical, noting an enterprise value of $13.1 billion. Also of note, the US Food and Drug Administration (FDA) has approved Swiss drugmaker Basilea’s antibiotic Zevtera for three indications. 7 April 2024
Biotechnology
The US Food and Drug Administration on Friday granted accelerated approval to Enhertu (fam-trastuzumab deruxtecan-nxki) for adult patients with unresectable or metastatic HER2-positive (IHC3+) solid tumors. 6 April 2024
Pharmaceutical
Following its initial investigation into the acquisition by Theramex of certain drug rights held by Viatris, the UK’s antitrust body has said the transaction: “could reduce competition and choice for hormone replacement therapy treatments.” 5 April 2024
Pharmaceutical
The UK’ Medicines and Healthcare products Regulatory Agency (MHRA) has today approved Exblifep, the combined antibiotic cefepime/enmetazobactam. 4 April 2024
Pharmaceutical
A second Expert View piece from Xandra Neuberger, associate director, regulatory affairs and international service lead for clinical trial applications at PharmaLex. 4 April 2024
Pharmaceutical
The US Food and Drug Administration approved Zevtera (ceftobiprole medocaril sodium for injection), developed by Swiss drugmaker Basilea Pharmaceutica. 4 April 2024
Biotechnology
UCB's Bimzelx (bimekizumab-bkzx) has taken a step closer to a new US approval, with the regulator accepting a supplemental Biologics License Application in hidradenitis suppurativa (HS). 4 April 2024
Pharmaceutical
First approved in 2009 as a treatment for schizophrenia, Vanda Pharmaceuticals’ Fanapt (iloperidone) has now won US regulatory approval for a new indication, with the news sending the US drugmaker’s shares up 33% to $5.23. 4 April 2024
Biosimilars
The landscape of biosimilars has rapidly evolved over the past decade, with the US Food and Drug Administration (FDA) spearheading efforts to enhance their approval and utilization. 3 April 2024
Biotechnology
Adding to recent setbacks in the development of Leqembi (lecanemab), US firm Biogen (Nasdaq: BIIB) has revealed a filing for a subcutaneous formulation will be delayed. 3 April 2024
Generics
The US Food and Drug Administration (FDA) yesterday published the draft guidance for industry, “Data Integrity for In Vivo Bioavailability and Bioequivalence Studies.” 3 April 2024
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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