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Regulatory Updates

Set Alert for Regulatory Updates

AstraZeneca To Challenge GSK After Clinching Lupus Drug Approval

Fears that US regulators would take issue with AstraZeneca's decision to change the endpoints of a second pivotal trial for anifrolumab were unfounded and the first-in-class type I interferon inhibitor is the first new treatment for systemic lupus erythematosus in more than 10 years.

Approvals Immune Disorders

Pipeline Watch: Phase III Readouts For COVID-19, Alzheimer's And Cancer Pain

Pipeline Watch is a weekly snapshot of selected late-stage clinical trial events and approvals announced by pharmaceutical and biotech companies at medical and industry conferences, in financial and company presentations, and in company releases and statements.

Pipeline Watch Approvals

The Wait For Inspections: Biocon Seeks FDA Stance On Mutual Recognition Agreement Route

Biocon is awaiting a scheduled FDA pre-approval inspection for insulin aspart at its facility in Malaysia, amid concerns that the surge in COVID-19 cases in the Southeast Asian nation may cloud timelines. The Indian firm is also pursuing a mutual recognition agreement route with the agency for a generic product approval.

Biosimilars Regulation

GSK’s Shingrix Vaccine Can Reach Millions More

The shingles vaccine could potentially be used in about three million immunocompromised people, according to GSK, but CDC’s advisory committee will weigh in with recommendations.

Approvals Vaccines

France's Erytech Closer To Realizing Market Ambitions With Eryaspase US Filing

It has taken almost two decades but it looks as though Erytech could get approval for eryaspase in the US in two indications next year – acute lymphoblastic leukemia and pancreatic cancer.

Cancer Business Strategies

Pipeline Watch: Phase III Starts In Hemophilia, Alzheimer's

Pipeline Watch is a weekly snapshot of selected late-stage clinical trial events and approvals announced by pharmaceutical and biotech companies at medical and industry conferences, in financial and company presentations, and in company releases and statements.

Pipeline Watch Approvals

Albireo Dashes Into PFIC Market As FDA, EMA Approve Bylvay

The company anticipates an addressable global market for progressive familial intrahepatic cholestasis of 2,500 patients, with initial plans to focus on around 100 physicians at 60 centers.

Rare Diseases Approvals

Almirall Focus Firmly On Lebrikizumab After Securing Klisyri Approval

Now that the actinic keratosis treatment Klisyri has got the green light in Europe, the Spanish firm's attention will be on atopic dermatitis and forthcoming Phase III data on lebrikizumab, a potential rival to Dupixent.

Approvals Dermatology

Coronavirus Update: Japan Approves Antibody Cocktail In Short Order

Japan has granted an emergency approval to Chugai/Roche/Regeneron's antibody cocktail after a rapid review, while India has emerged as one of the top purchasers globally of COVID-19 vaccines as it looks to protect more of its population. 

Coronavirus COVID-19 Commercial

Stock Watch: Poxel Passes Go…But To Where?

Poxel’s shift to new therapeutic areas may be necessary despite Japan’s approval for its diabetes drug. Twymeeg looks set to be hamstrung by placebo-controlled studies without outcomes data.

Approvals Commercial

Pipeline Watch: Phase III Readouts In COVID-19, Crohn's Disease

Pipeline Watch is a weekly snapshot of selected late-stage clinical trial events and approvals announced by pharmaceutical and biotech companies at medical and industry conferences, in financial and company presentations, and in company releases and statements.

Pipeline Watch Approvals

Coronavirus Update: EMA To Update Comirnaty And Spikevax Labels On Cardiac Safety

Comirnaty and Spikevax to get EU label update on cardiac safety, Japanese filing for REGEN-COV, plus vaccine progress for ReiThera and Genexine.

Coronavirus COVID-19 Vaccines
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