- Innovent and Eli Lilly’s Biologics License Application (BLA) for sintilimab – branded as “Tyvyt” in China – is seeking approval for the IgG4 PD-1 inhibitor in combination with pemetrexed and platinum-based chemotherapy for the first-line treatment of adult patients with stage IIIB or IIIC or stage IV non-squamous non-small cell lung cancer (NSCLC) with no EGFR or ALK genomic tumor aberrations. The BLA has come under fire by the U.S. Food and Drug Administration (FDA) because the ORIENT-11 trial included only a single ethnic group, and as outlined in the Code of Federal Regulations (FCR), there are three requirements for use of foreign data: 1) The foreign data are applicable to the U.S. population and U.S. medical practice; 2) the studies have been performed by clinical investigators of recognized competence; and 3) FDA is able to validate the data through an on-site inspection or other appropriate means.
- Japan’s Health Ministry has issued fast-track approval for Pfizer’s COVID-19 antiviral pill, Paxlovid (nirmatrelvir + ritonavir) in the treatment of patients with mild symptoms. The committee members were somewhat hesitant to OK Paxlovid because ritonavir is unable to be taken at the same time as medications for high blood pressure, among other drugs. With these risks in mind, an initial group of 2,000 medical institutions will prescribe Paxlovid until February 27, after which others will follow suit.
- The UK’s National Health Service (NHS) has announced it has agreed on early access to GlaxoSmithKline’s (GSK) Jemperli (dostarlimab) through the Cancer Drugs Fund (CDF) to treat women who have advanced uterine cancer.
Nigeria has taken delivery of almost 2 million doses of Johnson & Johnson’s (J&J) COVID-19 vaccine from the European Union (EU). Speaking at an official hand-over ceremony in Abuja, the EU Ambassador to Nigeria and the Economic Community of West African States (ECOWAS), Samuela Isopi, said the donation by Greece, Finland and Slovenia through COVAX is part of a global donation of almost 20 million J&J doses from EU member states to Nigeria, with additional contributions from the EU expected to follow in the coming weeks.
Merck and Ridgeback Biotherapeutics announced that roughly 3.1 million courses of their investigational oral COVID-19 antiviral, molnupiravir, are in the hands of the U.S. government to distribute to Americans.
South Africa’s Afrigen Biologics is hoping to test its COVID-19 vaccine based on the publicly available sequence of Moderna’s mRNA COVID-19 vaccine Spikevax in humans by the end of this year. The company’s COVID-19 vaccine would be the first vaccine made without assistance or approval from the developer, as well as the first mRNA fully produced in Africa.
The European Medicines Agency (EMA) has announced it has started to evaluate an application for the use of a booster dose of Pfizer-BioNTech’s COVID-19 vaccine, Comirnaty, in adolescents aged 12 to 15 years as well as an ongoing application in adolescents aged 16 to 17 years.
RedHill Biopharma, a biopharmaceutical company based in Israel, announced promising results from a phase 2/3 study evaluating patients who received opaganib on top of remdesivir and corticosteroids, the best available standard of care (SoC) for hospitalized COVID-19 patients.
Celltrion Group submitted an Investigational New Drug (IND) application to carry out a global phase 3 trial evaluating an inhaled antibody cocktail therapy for patients with mild to moderate symptoms of COVID-19.
Humanigen has announced the launch of LenzMAP, the managed access program for lenzilumab, for certain hospitalized COVID-19 patients.
Novartis has requested Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration (FDA) for ensovibep, a DARPin antiviral therapeutic candidate for the treatment of COVID-19.
Moderna announced it has inked a new supply agreement with Colombia for 10.8 million doses of the company’s COVID-19 vaccine. The new supply is on top of 10 million doses already delivered to Colombia last year. The doses are planned for gradual delivery over the course of 2022, with 1 million doses in the first quarter, 6 million doses in the second quarter, and 3.8 million doses in the third quarter.
Through the Cancer Moonshot initiative first launched in 2016, U.S. President Joe Biden wants to reduce the cancer death rate by 50% over the next 25 years and improve the lives of those living with and surviving cancer by increasing cancer screening and early detection.
The Ontario Ministry of Health has updated its guidelines for drug submission and evaluation. The guidelines have been amended to streamline the process by simplifying the drug submission and evaluation policy documents. Specific guidelines for different types of products – now available on the ministry’s website – include Ontario Guidelines for Single-Source Drug Products, Ontario Guidelines for Biosimilar Products, and Ontario Guidelines for Multiple-Source Drug Products, to name a few.
The Canadian Agency for Drugs and Technologies in Health (CADTH) has announced the creation of the Post-Market Drug Evaluation (PMDE) Program with the aim of delivering “timely and credible” evidence on the post-market safety and effectiveness of drugs approved in Canada.
The National Institute for Health and Care Excellence (NICE) has confirmed the new prices for technology appraisals and highly specialized technologies evaluations, which come into effect April 1, 2022. As of April 1, 2019, NICE has been charging drug makers for its technology appraisal (TA) and highly specialized technologies (HST) guidance.
The Center for Biologics Evaluation and Research (CBER), a part of the U.S. Food and Drug Administration (FDA), has published a list of guidance topics it may develop sometime in 2022. Among the topics are class-specific recommendations for developing biosimilars and biologics, exclusivity periods for generics, decentralized clinical trials, drug development tools including biomarker qualification, and the identification of trade partners under the Drug Supply Chain Security Act.
The National Institute for Health and Care Excellence (NICE) has published draft guidance recommending Novo Nordisk’s Wegovy (semaglutide) to treat adults with at least one weight-related condition and a body mass index (BMI) of at least 35 kg/m2 and, exceptionally, to people with a BMI of 30.0 kg/m2 to 34.9 kg/m2.
The Institute for Clinical and Economic Review (ICER) announced that it will assess two amyotrophic lateral sclerosis (ALS) treatments, including AMX0035 by Amylyx Pharmaceuticals and oral edaravone by Mitsubishi Tanabe Pharma Development America.
The High Health Authority (HAS) has approved an extension of indication for the reimbursement of Amgen’s orphan drug Blincyto (blinatumomab) to treat patients above one year of age with acute precursor B-expressing CD19 B-cell lymphocytic leukemia (ALL) who are Philadelphia-chromosome-negative (Ph-negative).
PRICING & REIMBURSEMENT
Roche’s Evrysdi (risdiplam) has been approved for reimbursement in Italy when used for the treatment of 5q spinal muscular atrophy (SMA) in patients from two months of age with a clinical diagnosis of SMA Type 1, Type 2 or Type 3 or who have one to four copies of SMN2. According to the Official Gazette, Evrysdi 0.75 mg/ml powder for the oral solution has an ex-factory price (excluding VAT) of EUR 8,285.00 and a retail price (including VAT) of EUR 13,673.56.
AbbVie and the pan-Canadian Pharmaceutical Alliance (pCPA) have reached an agreement on Venclexta (venetoclax) in combination with azacitidine for the treatment of patients with newly diagnosed acute myeloid leukemia (AML) who are 75 years or older or who have comorbidities precluding use of intensive induction therapy.
The Scottish Medicines Consortium (SMC) has completed its February 2022 meeting, issuing advice on six new therapies for use in certain conditions, including a rare lung cancer caused by occupational exposure to asbestos and a severely disabling muscle-wasting disease. SMC chairman Mark MacGregor said, “The committee is pleased to be able to accept these medicines for use by NHSScotland,” which include Opdivo (nivolumab), Evrysdi (risdiplam), Epidyolex (cannabidiol), Ontozry (cenobamate), Pemazyre (pemigatinib) and Xtandi (enzalutamide).
The Danish Medicines Council has recommended Swedish Orphan Biovitrum’s Doptelet (avatrombopag) for the treatment of primary chronic immune thrombocytopenia (ITP) in adult patients who are refractory to other treatments (e.g., corticosteroids, immunoglobulins).
Roche Canada announced it has wrapped up negotiations with the pan-Canadian Pharmaceutical Alliance (pCPA) over Evrysdi (risdiplam) for the treatment of spinal muscular atrophy (SMA) in patients two months of age or older.
The Medicines and Healthcare products Regulatory Agency (MHRA) has granted Innovation Passport to Theragnostics’ novel I-123 PARPi (THG-009) therapeutic agent for the treatment of primary and recurrent glioblastoma multiforme (GBM).
The U.S. Food and Drug Administration (FDA) has approved Viatris’s Abbreviated New Drug Application (ANDA) for the first generic to Allergan’s Restasis (cyclosporine ophthalmic emulsion 0.05%).
The FDA has also approved Sanofi’s humanized monoclonal antibody, Enjaymo (sutimlimab-jome), to decrease the need for red blood cell transfusion due to hemolysis in adults with cold agglutinin disease (CAD).
The Scottish Medicines Consortium (SMC) has approved Biogen’s Vumerity (diroximel fumarate) for the treatment of adults living with relapsing-remitting multiple sclerosis (RRMS).
Gamida Cell, a cancer-focused advanced cell therapy company, announced it has kicked off the Biologics License Application (BLA) rolling submission process for omidubicel in blood cancer patients in need of a stem cell transplant.
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