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Pharmaceutical
China's top price regulator will soon launch "large-scale and systematic" anti-trust investigations into drug companies, both foreign and domestic, after it recently summoned them to collect data and information, said a source close to the regulator reported by China Daily. 7 May 2016
Biotechnology
UK medicines cost-effectiveness watchdog the National Institute for Health and Care Excellence (NICE) has recommended US pharma major AbbVie’ Humira (adalimumab) for the treatment of active moderate to severe hidradenitis suppurativa (HS). 6 May 2016
Biotechnology
UK government medicines cost-effectiveness body the National Institute for Health Care Excellence (NICE) has published new draft guidance recommending two new treatment options for suitable patients with conditions that put them at extremely high risk of heart attacks or strokes. 6 May 2016
Pharmaceutical
The UK’s Early Access to Medicines scheme (EAMS) is not achieving what it set out to do and is not fit for purpose in a competitive global pharmaceuticals market, a conference has heard. 5 May 2016
Pharmaceutical
A new scheme which aims to accelerate the development and approval of new medicines in areas of unmet medical need in Europe attracted 18 applications in its first month, it has been revealed. 5 May 2016
Biotechnology
Halaven (eribulin), a drug marketed by Japanese pharma major Eisai, is to become available for European patients with advanced liposarcomas after receiving regulator approval. 5 May 2016
Pharmaceutical
A recent review of data from clinical trials and post-marketing experience has shown that hepatitis B virus (HBV) reactivation can occur in chronic HBV carriers, after they received BCR-ABL tyrosine kinase inhibitors (TKIs). 5 May 2016
Biotechnology
This week's Federal Budget revealed a welcome response to the Review of Medicines and Medical Devices Regulation (The Pharma Letter May 3), that will provide industry with savings of around A$75 million (~$57 million) per annum. 5 May 2016
Pharmaceutical
An event next month is being billed as a chance to build on Chinese pharma’s potential as the country seeks foreign backers to make the most of its investment opportunities. 4 May 2016
Pharmaceutical
The US Food and Drug Administration yesterday warned that compulsive or uncontrollable urges to gamble, binge eat, shop, and have sex have been reported with the use of the antipsychotic drug aripiprazole. 4 May 2016
Biotechnology
Medicines regulator Health Canada has issued a health warning on US biotech major Gilead Sciences’ blood cancer drug Zydelig (idelalisib). 4 May 2016
Pharmaceutical
The German Institute for Quality and Efficiency in Health Care (IQWiG) has now examined Nucala (mepolizumab), from UK pharma major GlaxoSmithKline, in an early benefit assessment as to whether the drug offers an added benefit for patients in comparison with the appropriate comparator therapy. 3 May 2016
Pharmaceutical
Swiss drugmaker Santhera Pharmaceuticals has submitted briefing material and a meeting request to the US Food and Drug Administration (FDA) to discuss the filing of a New Drug Application (NDA) for Raxone (idebenone) for the treatment of Duchenne muscular dystrophy (DMD) patients not taking concomitant glucocorticoids, the company announced. 3 May 2016
Pharmaceutical
The US Food and Drug Administration has approved a brand name change for the antidepressant Brintellix (vortioxetine) to decrease the risk of prescribing and dispensing errors resulting from name confusion with the blood-thinning medicine Brilinta (ticagrelor), from AstraZeneca. 3 May 2016
Pharmaceutical
Drugmakers in mainland China and Taiwan who wish to access the two markets in a faster manner now have a solution, reports The Pharma Letter's local correspondent Wang Fangqing. 2 May 2016
Pharmaceutical
Following the abandoned $160 billion acquisition of Allergan by Pfizer, industry watchers started thinking that the record M&A activity of last year might slow down. However, the last few days of April proved this may not be the case, with three “billion-dollar” deals announced valued at a total of $45 billion. 2 May 2016
Biotechnology
The US Food and Drug Administration has approved biotech firm Acadia Pharmaceuticals’ Nuplazid (pimavanserin) for the treatment of hallucinations and delusions associated with Parkinson’s disease psychosis. 1 May 2016
Generics
The US Food and Drug Administration on Friday approved the first generic version of Crestor (rosuvastatin calcium), a copy of Anglo-Swedish pharma major AstraZeneca’s blockbuster cholesterol drug that is facing patient expiries. 1 May 2016
Pharmaceutical
At its April meeting, the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) issued positive recommendation for six new medicines, including a new antibiotic, for use in the European Union, and a positive scientific opinion for the use of a gel outside the EU 30 April 2016
Pharmaceutical
The US Food and Drug Administration has approved German pharma major Bayer’s Gadavist (gadobutrol) injection for use with magnetic resonance angiography (MRA) to evaluate known or suspected supra-aortic or renal artery disease in adult and pediatric patients (including term neonates). 30 April 2016
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 BeOne Medicines, formerly 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
In what could be construed to be India's quest for pharmaceutical supremacy, a clarion call has been made for the country to set its indigenous standards. 25 November 2024
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