Pharma & Biotech Pricing, Policy & Regulation
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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Pharmaceutical
East Coast, USA-based Agios Pharmaceuticals has won approval in the USA for Tibsovo (ivosidenib), a treatment for certain patients with relapsed or refractory acute myeloid leukemia. 20 July 2018
Pharmaceutical
Shares in Mersana Therapeutics plummeted over 40% after the firm announced the US regulator had put a partial clinical hold on a Phase I study of XMT-1522, following a patient death. 20 July 2018
Pharmaceutical
As Novartis and now Merck & Co move to grab the price-cutting spotlight from Pfizer, US Health Secretary Alex Azar revealed a new approach to drug importation on Thursday that could have a more far reaching impact on prices. 20 July 2018
Pharmaceutical
Following Pfizer’s promised price hike deferral and Novartis’ (NOVN: VX) decision to do the same, New Jersey’s Merck & Co has announced that it too will hold off on raising prices for now. 20 July 2018
Pharmaceutical
This week, the UK Parliament voted 305-301 in favor of continuing the UK’s involvement with the European Medicines Agency (EMA) after the nation leaves the European Union. But what does this mean for the pharmaceutical industry and patient healthcare after 2020? 19 July 2018
Pharmaceutical
Shanghai, China-based Green Valley Pharmaceutical today announced that its Phase III Study of sodium oligomannurarate (GV-971) capsules on mild-to-moderate Alzheimer's disease met its primary endpoint. 19 July 2018
Biotechnology
Swiss pharma giant Roche has been awarded a Breakthrough Therapy badge for a combination of Tecentriq (atezolizumab) and Avastin (bevacizumab) against hepatocellular carcinoma (HCC) in the first-line setting. 19 July 2018
Biotechnology
The US Food and Drug Administration today approved Kisqali (ribociclib) in combination with an aromatase inhibitor for the treatment of pre/perimenopausal or postmenopausal women with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer, as initial endocrine-based therapy. 19 July 2018
Pharmaceutical
Four years after its initial approval in moderate to severe Crohn’s disease, Japan’s Takeda Pharmaceutical has finally submitted Entyvio (vedolizumab) for approval in its home country. 18 July 2018
Pharmaceutical
The European Union and Japan have agreed to broaden the range of medicines for which they will recognize each other’s inspections of manufacturing sites. 18 July 2018
Pharmaceutical
The US Food and Drug Administration has approved Janssen’s four-in-one HIV-1 therapy Symtuza (cobicistat/darunavir ethanolate/emtricitabine/tenofovir alafenamide fumarate), following on from European approval, granted in September 2017. 18 July 2018
Biotechnology
Vertex Pharmaceuticals says it received a proposal from NHS England regarding its portfolio of cystic fibrosis medicines, notably Orkambi (lumacaftor/ivacaftor), the first drug directed at treating the cause of the disease. 18 July 2018
Pharmaceutical
In response to a Health and Human Services Department request, trade group Pharmaceutical Research and Manufacturers of America (PhRMA) has announced a new policy position on how payments should work in the supply chain. 18 July 2018
Pharmaceutical
Just as the European Medicines Agency is preparing for its post Brexit relocation to the Netherlands, and is implementing the next phase of its business continuity plan (BCP) to facilitate the move to Amsterdam, the EMA has published the first report on the implementation of its flagship policy on the publication of clinical data (Policy 0070). 17 July 2018
Biotechnology
New Zealand’s Pharmaceutical Management Agency PHARMAC said today that is progressing work aimed at improving funded access to medicines for rare disorders. 16 July 2018
Biotechnology
The UK’s health technology assessor has provided a draft guidance recommending reimbursement for AstraZeneca’s biologic asthma option Fasenra (benralizumab). 16 July 2018
Generics
Indian pharma major Lupin saw its shares fall 3.75% to 833.15 rupees this morning despite announcing that it has received approval from the UK health regulator for its Goa manufacturing facility. 16 July 2018
Pharmaceutical
Sweden’s Camurus says the US Food and Drug Administration has provided an action date of December 26, 2018 for the firm’s regulatory filing for CAM2038, an investigational opioid use disorder (OUD) treatment. 16 July 2018
Biotechnology
Greg Hunt, Australian MP for Flinders and Minister of Health, has announced the government's intention to invest A$250,000 ($186,000) to improve access to four immuno-oncology (I-O) therapies. 16 July 2018
Generics
On Friday, the US Food and Drug Administration alerted health care professionals and patients of a voluntary recall of several drug products containing the active ingredient valsartan, used to treat high blood pressure and heart failure. 16 July 2018
Biotechnology
PTC Therapeutics is to sell its rare pediatric disease priority review voucher (PRV) for $150 million. 28 November 2024
Pharmaceutical
A new indication for olverembatinib, developed by Suzhou-based Ascentage Pharma will be added to China’s National Reimbursement Drug List (NRDL) from next year. 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
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