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  • FDA Approves First Generic of Restasis
    4 February 2022

    FDA Approves First Generic of Restasis

    The U.S. Food and Drug Administration has approved the first generic of Restasis (cyclosporine ophthalmic emulsion) 0.05% single-use vials (eye drops) to increase tear production in patients whose tear production is presumed to be suppressed due to ocular inflammation associated with keratoconjunctivitis sicca (commonly known as dry eye). Increased tear production was not seen in patients currently taking topical anti-inflammatory drugs or using punctal plugs.

  • Novavax COVID-19 vaccine Nuvaxovid approved by MHRA
    4 February 2022
    Novavax COVID-19 vaccine Nuvaxovid approved by MHRA

    Nuvaxovid, the COVID-19 vaccine developed by Novavax, has today been given regulatory approval by the Medicines and Healthcare products Regulatory Agency (MHRA).  Nuvaxovid becomes the fifth COVID-19 vaccine authorised by the UK’s independent medicines regulator.

  • Gilead Sciences to settle HIV drug dispute with GSK in 1.25 billion USD
    3 February 2022
    Gilead Sciences to settle HIV drug dispute with GSK in 1.25 billion USD

    GlaxoSmithKline plc announced that ViiV Healthcare, the global specialist HIV company majority-owned by GSK, with Pfizer Inc. and Shionogi & Co. Limited Shionogi as shareholders, has agreed to settle the global patent infringement litigation between GSK, Shionogi and Gilead Sciences, Inc. Gilead concerning ViiV Healthcares patents relating to dolutegravir, an antiretroviral medication used, together with other medicines, to treat human immunodeficiency virus.

  • After FDA recommendation, Pfizer and BioNTech preparing regulatory submission of their COVID-19 vaccine for below 5 years children
    3 February 2022
    After FDA recommendation, Pfizer and BioNTech preparing regulatory submission of their COVID-19 vaccine for below 5 years children

    Pfizer Inc and BioNTech SE announced that following a request from the U.S. Food and Drug Administration the companies have initiated a rolling submission seeking to amend the Emergency Use Authorization of the Pfizer-BioNTech COVID-19 Vaccine to include children 6 months through 4 years of age 6 months to <5 years of age, in response to the urgent public health need in this population. The companies expect to complete the EUA submission in the coming days.

  • Alembic Pharmaceuticals receives USFDA Tentative Approval for Fesoterodine Fumarate Extended-Release Tablets
    3 February 2022
    Alembic Pharmaceuticals receives USFDA Tentative Approval for Fesoterodine Fumarate Extended-Release Tablets

    Alembic Pharmaceuticals Limited announced that it has received tentative approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Fesoterodine Fumarate Extended- Release Tablets, 4 mg and 8 mg. The tentatively approved ANDA is therapeutically equivalent to the reference listed drug product (RLD) Toviaz Extended-Release Tablets, 4 mg and 8 mg, of Pfizer Inc. (Pfizer).

  • Pfizer and Ionis Announce Discontinuation of Vupanorsen Clinical Development Program
    2 February 2022
    Pfizer and Ionis Announce Discontinuation of Vupanorsen Clinical Development Program

    Pfizer Inc and Ionis Pharmaceuticals, Inc announced the discontinuation of the Pfizer-led clinical development program for vupanorsen (PF-07285557), an investigational antisense therapy that was being evaluated for potential indications in cardiovascular (CV) risk reduction and severe hypertriglyceridemia (SHTG).

  • Mankind Pharma to buy domestic business of Panacea Biotec Pharma
    1 February 2022
    Mankind Pharma to buy domestic business of Panacea Biotec Pharma

    Mankind Pharma to buy domestic business of Panacea Biotec Pharma. Both companies entered into an agreement to buy the domestic formulations business of Panacea Biotec Pharma, a subsidiary of Sputnik V maker Panacea Biotec for Rs 1,908 crore.

  • Valneva Announces Initiation of Adolescent Phase 3 Trial for its Single-Shot Chikungunya Vaccine Candidate
    1 February 2022
    Valneva Announces Initiation of Adolescent Phase 3 Trial for its Single-Shot Chikungunya Vaccine Candidate

    Valneva SE a specialty vaccine company, today announced the initiation of a Phase 3 trial in adolescents for its single-shot chikungunya vaccine candidate, VLA1553.

  • CHMP recommends approval of Dupixent® (dupilumab) for children aged 6 to 11 years with severe asthma with type 2 inflammation
    31 January 2022
    CHMP recommends approval of Dupixent® (dupilumab) for children aged 6 to 11 years with severe asthma with type 2 inflammation

    The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion recommending to extend the approval of Dupixent® (dupilumab) in the European Union (EU) to include add-on maintenance treatment for children aged 6 to 11 years with severe asthma with type 2 inflammation characterized by raised blood eosinophils and/or raised fractional exhaled nitric oxide (FeNO) who are inadequately controlled on two maintenance therapies.

  • Sun Pharma launches PrCEQUA in Canada
    29 January 2022
    Sun Pharma launches PrCEQUA in Canada

    Sun Pharma Canada Inc Limited announced the launch of CEQUA, a new treatment for Canadians living with dry eye disease. CEQUA (cyclosporine ophthalmic solution 0.09% w/v), a calcineurin inhibitor immunomodulator, is the first dry eye treatment available in Canada that is delivered with nanomicellar (NCELL) technology, which improves the bioavailability and physicochemical stability of cyclosporine to increase ocular tissue penetration.

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