Regulation
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Pharmaceutical
Industry is showing a very high level of readiness for upcoming new packaging and labelling measures impacting the UK market, according to the Medicines and Healthcare products Regulatory Agency (MHRA). 29 November 2024
Biotechnology
PTC Therapeutics is to sell its rare pediatric disease priority review voucher (PRV) for $150 million. 28 November 2024
Biotechnology
The UK subsidiary of Dutch drugmaker argenx confirmed today that its investigational therapy, subcutaneous efgartigimod alfa has been granted Promising Innovative Medicine (PIM) designation by the UK Medicines and Healthcare products Regulatory Agency (MHRA) for the treatment of adults with chronic inflammatory demyelinating polyneuropathy (CIDP). 28 November 2024
Pharmaceutical
The first iteration of the European Shortages Monitoring Platform (ESMP) has gone live. 28 November 2024
Pharmaceutical
The US Food and Drug Administration (FDA) has issued a Complete Response Letter (CRL) for the New Drug Application (NDA) for govorestat, a novel, central nervous system (CNS)-penetrant aldose reductase inhibitor (ARI), for the treatment of classic galactosemia, under development by Applied Therapeutics. 28 November 2024
Biotechnology
The US Food and Drug Administration has received new reports of hematologic malignancies, including life-threatening cases of myelodysplastic syndrome (MDS) and acute myeloid leukemia (AML), following treatment of early, active cerebral adrenoleukodystrophy (CALD) patients with Skysona (elivaldogene autotemcel). 28 November 2024
Generics
The US Food and Drug Administration (FDA) yesterday announced its Fiscal Year 2025 Generic Drug User Fee Amendments (GDUFA). 28 November 2024
Pharmaceutical
UK-based drugmaker Advanz Pharma has announced that following the grant of a temporary suspension, as announced on last month, the General Court of the European Union (General Court) has decided not to further extend the suspension of the European Commission (EC) decision to revoke the conditional marketing authorization (CMA) for Ocaliva (obeticholic acid) in Europe. 28 November 2024
Biotechnology
The European medicines regulator has approved a combo therapy starring PD-1 inhibitor Tevimbra (tislelizumab), from cancer firm BeiGene. 27 November 2024
Biotechnology
After trading closed yesterday, Exelixis revealed that the US Food and Drug Administration (FDA) has notified the company that the supplemental New Drug Application (sNDA) for cabozantinib (Cabometyx) for the treatment of adults with previously treated advanced pancreatic neuroendocrine tumors (pNET) and advanced extra-pancreatic NET (epNET) will be discussed at an Oncologic Drugs Advisory Committee (ODAC) meeting in March 2025. 27 November 2024
Pharmaceutical
The European Commission (EC) has approved a single-vial, fully liquid presentation of Menveo (meningococcal Group A, C, W-135 and Y conjugate vaccine, MenACWY vaccine) to help protect against invasive meningococcal disease (IMD) caused by bacterial serogroups A, C, W and Y, UK pharma major GSK announced today. 27 November 2024
Pharmaceutical
Novartis announced today that the European Commission (EC) has approved Kisqali (ribociclib) in combination with an aromatase inhibitor (AI) for the adjuvant treatment of patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative early breast cancer (EBC) at high risk of recurrence. 27 November 2024
Biotechnology
Chengdu-based Kelun-Biotech has received marketing authorization in China for sacituzumab tirumotecan (sac-TMT), a Trop2-directed antibody-drug conjugate (ADC). 27 November 2024
Pharmaceutical
The Biden administration has proposed a new rule that could significantly expand Medicare and Medicaid coverage for obesity medications, potentially benefiting millions of Americans. 27 November 2024
Pharmaceutical
The US Food and Drug Administration (FDA) has extended the review period for Soleno Therapeutics’ the New Drug Application (NDA) for DCCR (diazoxide choline) extended-release tablets 27 November 2024
Pharmaceutical
Japanese drugmaker Otsuka has announced the submission of a New Drug Application (NDA) to the Japanese Ministry of Health, Labor and Welfare (MHLW) for the manufacture and sale in Japan of bempedoic acid - trade name Nexletol in Japan - for the treatment of hypercholesterolemia and familial hypercholesterolemia. 27 November 2024
Pharmaceutical
Berlin, Germany-based Eckert & Ziegler Radiopharma has received approval of its proprietary non-carrier added Lutetium-177 chloride, Theralugand, by the European Commission (EC). 27 November 2024
Biotechnology
The US Food and Drug Administration (FDA) has accepted for review a Biologics License Application (BLA) for belantamab mafodotin in combinations with bortezomib plus dexamethasone (BorDex [BVd]) and pomalidomide plus dexamethasone (PomDex [BPd]) for multiple myeloma patients who have received at least one prior line of therapy. 25 November 2024
Pharmaceutical
The US Food and Drug Administration (FDA) has approved Imkeldi (imatinib) oral solution, the first oral liquid form of imatinib to treat certain forms of leukemia and other cancers, from privately-held US-Ireland-based pharmaceutical company Shorla Oncology. 25 November 2024
Biotechnology
StemCyte, a subsidiary of StemCyte International, has secured approval from the US Food and Drug Administration for Regenecyte, a cord blood-derived stem cell therapy. 25 November 2024
Pharmaceutical
Japanese drug major Eisai said its activity in the UK may be impacted by the substantial concessions to the NHS in a bid to continue the inclusion of its breast cancer treatment Halaven (eribulin) in the Cancer Drugs Fund (CDF). 23 July 2015
Pharmaceutical
A link has been established between the European Medicines Verification System and the German repository system, marking the first successful implementation of a Hub connection with a member state. 23 July 2015
Generics
Indian pharma companies may finally be looking at a better rate of clearances from the US Food and Drug Administration as the third year of GDUFA (Generic Drug User Fee Amendment of 2012) draws to a close. 22 July 2015
Pharmaceutical
The National Institute for Health and Care Excellence (NICE) has issued final guidance for Vargatef (nintedanib) from German family-owned pharma major Boehringer Ingelheim. 22 July 2015
Pharmaceutical
The National Institute for Health and Care Excellence (NICE), the medicines watchdog for England and Wales, has recommended National Health Service use of two ophthalmic products, in two separate pieces of final guidance published today. 22 July 2015
Pharmaceutical
The US Food and Drug Administration (FDA) has granted Breakthrough Therapy designation to the investigational compound BMS-663068 from Bristol-Myers Squibb. 21 July 2015
Pharmaceutical
The European commission has approved Opdivo (nivolumab) from Bristol-Myers Squibb for previously-treated advanced squamous non-small cell lung cancer. 21 July 2015
Pharmaceutical
New Zealand’s Pharmaceutical Management Agency PHARMAC is seeking feedback on a proposal to list Firazyr (icatibant) resulting from a provisional agreement formed between the local subsidiary of Ireland-headquartered Shire and PHARMAC. 21 July 2015
Biotechnology
US biotech major Amgen today announced that the European Commission (EC) has granted marketing authorization for Repatha (evolocumab). 21 July 2015
Biotechnology
US specialty biotech group Heron Therapeutics has resubmitted its New Drug Application for Sustol (granisetron) Injection. 20 July 2015
Biotechnology
Japanese pharma company Asahi Kasei has received approval for its regulatory application to the Japanese Pharmaceutical and Medical Device Agency for Xiaflex (collagenase clostridium histolyticum) to treat Dupuytren’s contracture in Japan. 20 July 2015
Pharmaceutical
The US Food and Drug Administration has granted orphan drug designation to investigational recombinant humanized anti-tau antibody, C2N-8E12 (ABBV-8E12), from US drugmaker AbbVie and C2N Diagnostics. 20 July 2015
Generics
Biosimilar injectables specialist Hospira has obtained approval from the US Food and Drug Administration for bivalirudin, a generic of Angiomax from The Medicines Company. 17 July 2015
Pharmaceutical
The US Food and Drug Administration has approved the supplemental Biologics License Application for Dysport (abobotulinumtoxinA) from Ipsen to treat upper limb spacisity in adult patients. 17 July 2015
Pharmaceutical
The European Commission has approved US pharma major Bristol-Myers Squibb’s Evotaz (atazanavir 300mg and cobicistat 150mg). 16 July 2015
Pharmaceutical
The US Food and Drug Administration, the European Commission and the European Medicines Agency have reviewed their cooperation, especially regarding pharmacovigilance, biosimilars and pediatric medicine. 16 July 2015
Pharmaceutical
Reauthorization of the US Prescription Drug User Fee Act (PDUFA) has made meaningful improvements to the regulatory program, say trade groups Pharmaceutical Research and Manufacturers of America (PhRMA) and the Biotechnology Industry Organization (BIO). 16 July 2015
Biosimilars
A new report from RnRMarketResearch, Japan Pharma Outlook 2015: 2015 -Year to Watch out for Authorized Generics, Biosimilars and Overseas Strategic Initiatives, says most of the companies are revalidating their domestic (and thus overseas) strategies to adapt to new regulations. 16 July 2015
Generics
The European Medicines Agency has released for consultation product-specific guidance on bioequivalence studies for four active substances. 15 July 2015
Biosimilars
South Korea’s Celltrion has received approval to sell its Remsima from the Ministry of Health of the Russian Federation (Minzdrav) on July 13, reported BusinessKorea. 15 July 2015
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