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US FDA to consider Dizal’s first-in-class lung cancer drug

Shanghai-based Dizal has made a submission to the US Food and Drug Administration, seeking approval for sunvozertinib. 8 November 2024

Health Canada approval for Moderna’s RSV vaccine

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

J&J files with EMA and FDA for Darzalex in high-risk smouldering MM

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

FDA Rare Pediatric Disease status for AskBio’s AB-1003

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

Acadia Pharma sells priority review voucher for $150 million

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

GSK’s Arexvy receives expanded approval in Canada

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

Another Dupixent approval in the EU

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

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FDA approves REMS, advancing new drug disposal option for opioid analgesics

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

EU sets date for decision on proposed $16.5 billion Catalent buy

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

Photocure’s Hexvix wins Chinese approval

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

FDA accepts Ionis NDA for donidalorsen

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

Disc Medicine leaps as it gets positive FDA feedback

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

FDA sets up Rare Diseases Innovation Hub

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

FDA Rare Pediatric Disease designation for BPGbio

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

The week in pharma: action, reaction and insight – week to November 1

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

FDA panel vote leaves Lexicon’s Zynquista hopes hanging by a thread

Texas-based biopharma Lexicon Pharmaceuticals was trading nearly 36% lower on Friday morning. 1 November 2024

Remove barriers for EU firms trading in other markets, group says

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

Sugemalimab approved to treat adult patients with NSCLC in UK

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

Novartis’ Scemblix gains FDA approval in newly diagnosed CML

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

FDA approves Protega’s Roxybond

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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FDA approves expanded use of Cresemba

The US Food and Drug Administration (FDA) on Friday approved Cresemba (isavuconazonium sulfate), an azole antifungal drug, for the treatment of invasive aspergillosis (IA) and invasive mucormycosis (IM) in pediatric patients. 11 December 2023

The week in pharma: action, reaction and insight – week to December 8, 2023

M&A featured strongly in the news last week. First, Swiss pharma giant Roche last Monday announced it is entering the weight-loss treatment market with a proposed $2.7 billion acquisition of USA-based Carmot Therapeutics. Also, US pharma major AbbVie announced an $8.7 billion takeover bid for USA-based Cerevel, aiming to expand its neurosciences portfolio. On the regulatory front, US pharma major Eli Lilly gained a second indication approval from the US Food and Drug Administration (FDA) for Jaypirca, this time for chronic lymphocytic leukemia or small lymphocytic lymphoma (CLL/SLL). Also, US healthcare giant Johnson & Johnson last week announced a wide-ranging review of its business, as one of its top selling drugs, Stelara, is reaching its sunset. 10 December 2023

Pfizer gains EC approval for Elrexfio in multiple myeloma

Adding to its US regulatory clearance in August, the European Commission (EC) has now also granted conditional marketing authorization for Elrexfio (elranatamab), from US pharma giant Pfizer. 8 December 2023

CStone's Cejemly approved in China for first-line ESCC

China’s National Medical Products Administration (NMPA) has approved the supplemental biologics license application (sBLA) for Cejemly (sugemalimab) alongside fluorouracil and platinum-based chemotherapy as a first-line treatment of unresectable locally advanced, recurrent, or metastatic esophageal squamous cell carcinoma (ESCC). 8 December 2023

New TGA warnings of romosozumab (Evenity) cardiovascular risks

Australian regulator the Therapeutic Goods Administration (TGA) says that its investigation into the risk of myocardial infarction and stroke in patients taking romosozumab (Evenity) found that stronger warnings regarding these risks were needed in the Product Information (PI) and Consumer Medicine (CMI) Information external sites. 8 December 2023

Ipsen delivers optimistic outlook and elafibranor update

French drugmaker Ipsen has had a busy Thursday - announcing an update on its overall outlook and elafibranor, a key pipeline prospect. 7 December 2023

Madrigal's efforts for resmetirom will set tone for future launches of NASH therapies, says analyst

Since the US Food and Drug Administration’s acceptance of Madrigal Pharmaceutical’s new drug application (NDA) and priority review for its THR-β agonist (resmetirom) in non-alcoholic steatohepatitis (NASH) in September 2023, the company has taken steps to fortify its leadership and financial position to gear up for the imminent launch of resmetirom. 7 December 2023

FDA delays review of Optinose's sNDA for Xhance

The US Food and Drug Administration (FDA) has extended by three months the review period of its supplemental new drug application (sNDA) requesting approval of Xhance (fluticasone propionate) as a treatment for chronic rhinosinusitis. 7 December 2023

As US FDA scrutiny intensifies on Indian drug facilities, a tangle of domestic factors deepens the challenge

In a major crackdown, the US Food and Drug Administration (FDA) has been conducting an increased number of inspections of pharmaceutical manufacturing facilities in India. 7 December 2023

Novartis receives FDA approval for Fabhalta in PNH

The US Food and Drug Administration (FDA) has approved Fabhalta (iptacopan) as the first oral monotherapy for the treatment of adults with paroxysmal nocturnal hemoglobinuria (PNH). 6 December 2023

FDA 'Breakthrough' status for Neurocrine's crinecerfont

Neurocrine Biosciences yesterday revealed it has received Breakthrough Therapy designation from the US Food and Drug Administration (FDA) for crinecerfont in congenital adrenal hyperplasia. 6 December 2023

J&J's TAR-200 wins breakthrough designation

Johnson & Johnson’s TAR-200 has been granted Breakthrough Therapy designation (BTD) to potentially treat patients with Bacillus Calmette-Guérin (BCG)-unresponsive high-risk non-muscle-invasive bladder cancer (HR-NMIBC), who are ineligible for or elected not to undergo radical cystectomy. 5 December 2023

Safety setback for BTK blockers as FDA holds fenebrutinib trial

Roche subsidiary Genentech has provided an update on its multiple sclerosis program, revealing a partial trial stoppage for the oral BTK inhibitor fenebrutinib. 5 December 2023

PharmaMar's Zepzelca gains approval in Macao

Spanish drugmaker PharmaMar has announced that its licensing partner, Luye Pharma Group, has received marketing approval for Zepzelca (lurbinectedin) in Macao. 5 December 2023

US DoJ readout of Reproductive Rights Task Force meeting

In the latest move in the USA for rights to contraceptives and abortion drugs, on Monday, the Reproductive Rights Task Force (RRTF) provided a briefing to Attorney General Merrick Garland and Task Force Chair Associate Attorney General Vanita Gupta on the Department of Justice’s (DoJ) work to protect reproductive freedom under federal law. 5 December 2023

EU approval next for UCB's Zilbrysq

The European Commission (EC) has granted a marketing authorization for Zilbrysq (zilucoplan) as an add-on to standard therapy for the treatment of generalized myasthenia gravis (gMG) in adults who are anti-acetylcholine receptor (AChR) antibody-positive. 4 December 2023

New FDA approval for Lilly's Jaypirca

The US Food and Drug Administration (FDA) on Friday approved another indication for Jaypirca (pirtobrutinib, 100mg and 50mg tablets) from US pharm major Eli Lilly . 4 December 2023

EFPIA response to EHDS report adopted in the European Parliament

The Environment and Civil Liberties committees adopted their position on creating a European Health Data Space (EHDS) to boost personal health data portability and more secure sharing. 4 December 2023

The week in pharma: action, reaction and insight – week to December 1, 2023

Among last week’s interesting research news, US biotech 89bio on Monday released encouraging new data on pegozafermin, its non-alcoholic steatohepatitis (NASH) candidate. Also, pharma major AbbVie reported long-awaited Phase II data for its lung cancer drug Teliso-V (telisotuzumab-vedotin). On the deal-making front, US RNA focused biotech Avidity Biosciences signed a collaboration with Bristol Myers Squibb, which could earn it as much as $2.3 billion. Of note, the US Food and Drug Administration (FDA) last week revealed it has received reports of T-cell malignancies associated with CAR-t cell therapy treatment and has instigated an investigation into the matter. AbbVie returned to the news limelight on Thursday, announcing it has reached agreement to acquire antibody-drug conjugates (ADCs) focused biotech ImmunoGen and its flagship cancer drug Elahere. 3 December 2023

EMA's PRAC recommends new pseudoephedrine measures

The European Medicines Agency’s (EMA) Pharmacovigilance Risk Assessment Committee (PRAC) has recommended new measures for medicines containing pseudoephedrine. 1 December 2023

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