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
Following on from a series of measures aimed at challenging the ongoing opioid addiction epidemic in the USA, the US Food and Drug Administration announced new action on Monday, with a set of revised scientific recommendations. 7 August 2018
Pharmaceutical
Pain Therapeutics has received a Complete Response Letter from the US Food and Drug Administration for its New Drug Application (NDA) for the abuse-deterrent opioid drug Remoxy ER (oxycodone) extended-release capsules CII. 6 August 2018
Pharmaceutical
The UK’s medicines regulator, the Medicines and Healthcare products Regulatory Agency (MHRA), has released an update on clinical trials regulations following the UK’s exit from the European Union, so-called “Brexit”. 6 August 2018
Pharmaceutical
The Institute for Clinical and Economic Review has issued a final report for AbbVie’s Orilissa (elagolix), raising serious questions over the affordability of the product. 6 August 2018
Biotechnology
The China National Drug Administration (CNDA) has approved Genvoya (elvitegravir 150mg/cobicistat 150mg/emtricitabine 200mg/tenofovir alafenamide 10mg or E/C/F/TAF) for the treatment of HIV-1 infection. 6 August 2018
Biotechnology
The USA’s Institute for Clinical and Economic Review (ICER) on Friday released a Final Condition Update report and Report-at-a-Glance on targeted immunomodulators for the treatment of moderate-to-severe plaque psoriasis. 6 August 2018
Pharmaceutical
In news last week, on the clinical trials front RedHill BioPharma attracted attention with its Phase III study of Crohn’s candidate RHB-104. There was disappointment for Sienna Biopharmaceuticals as its acne vulgar drug SNA-001 failed in a Phase III study, and Epizyme’s update on tazemetostat development for lymphoma caused some concern as the company lost 24% of its market value. Regulatory news included Progenics’ rare disease drug Azedra approval by the US Food and Drug Administration also elicited comment, as did European Union approval and pending launch of Amgen and Novartis’ migraine drug Aimovig. 5 August 2018
Generics
The US Food and Drug Administration is warning that the antibiotic azithromycin should not be given long-term to prevent a certain inflammatory lung condition in patients with cancers of the blood or lymph nodes who undergo a donor stem cell transplant. 4 August 2018
Biotechnology
The British Medicines and Healthcare Products Regulatory Agency (MHRA) has given the thumbs-up to Alnylam's experimental RNAi therapy patisiran. 3 August 2018
Pharmaceutical
Following action last month by both European and US regulators after the discovery of an impurity in certain medicines containing the blood pressure drug valsartan, the European Medicines Agency has issued its preliminary assessment of possible risks to patients. 3 August 2018
Biotechnology
The US Institute for Clinical and Economic Review (ICER) has announced plans to develop a report assessing the comparative clinical effectiveness and value of Novartis’ AVXS-101 and Biogen’s Spinraza (nusinersen) for treatment of spinal muscular atrophy (SMA). 3 August 2018
Pharmaceutical
Sanofi and Novartis have announced that they are forming plans to stockpile months' worth of drugs in UK facilities ahead of the country's uncertain departure from the European Union in March 2019. 2 August 2018
Pharmaceutical
Catalan pharma-chemical company Grifols announced on Wednesday that it had acquired 100% of Biotest Pharmaceuticals, expanding its US presence by almost 1,000 employees. 2 August 2018
Pharmaceutical
The US Food and Drug Administration (FDA) has granted breakthrough therapy designation to a drug in Phase III development for relapsed/refractory FLT3-ITD AML, a very aggressive form of the disease associated with poor prognosis and no approved targeted treatments. 1 August 2018
Pharmaceutical
As talks on the UK’s divorce settlement with the European Commission lumber on with still no resolution, the European Medicines Agency today said it will launch the next phase of its business continuity plan on October 1, 2018 at the latest. 1 August 2018
Pharmaceutical
US biotech firm Aegerion Pharmaceuticals has won European approval for Myalepta (metreleptin), a treatment for an ultra-rare condition called lipodystrophy, becoming the first and only licensed medication to treat the underlying problem of leptin deficiency. 1 August 2018
Pharmaceutical
The Australian government has added Fycompa (perampanel), a once-daily epilepsy treatment from Eisai, to the Pharmaceutical Benefits Scheme (PBS). 1 August 2018
Pharmaceutical
Japanese drugmaker Eisai and its American development partner Merck & Co have won Breakthrough Therapy designation for a combo of Lenvima (lenvatinib) and Keytruda (pembrolizumab). 1 August 2018
Pharmaceutical
The US Food and Drug Administration approved Mulpleta (lusutrombopag) for thrombocytopenia in adults with chronic liver disease who are scheduled to undergo a medical or dental procedure. 1 August 2018
Pharmaceutical
The US Food and Drug Administration has approved Azedra (iobenguane I 131) injection for intravenous use for the treatment of adults and adolescents age 12 and older with rare tumors of the adrenal gland (pheochromocytoma or paraganglioma) that cannot be surgically removed (unresectable), have spread beyond the original tumor site and require systemic anticancer therapy. 1 August 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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