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allergy

FDA knocks back Glenmark's allergic rhinitis therapy Ryaltris

Stocks in Indian pharmaceutical firm Glenmark were sent plummeting to a six-year low after it was confirmed that the FDA had raised concerns over the company’s New Drug Application for Ryaltris (olopatadinehydrochloride and mometasonefuroate) in the treatment of seasonal allergic rhinitis.

FDA approves Beximco's generic version of MSD's allergy drug Periactin

Bangladesh-based Beximco Pharma is celebrating following the decision from the FDA to approve its generic version of MSD’s antihistamine therapy Periactin (Cyproheptadine).

The 4mg generic tablet formulation is approved in the same indications as its reference product, including the treatment of allergy symptoms such as hives, sneezing, and itchy or watery eyes or nose.

Beximco said that the total market in the US for the mediciation was around $16 million in 2018.

Aimmune's peanut allergy therapy closes in on approval with promising Phase 3 data

Image Credit: Alpha Stock Images: http://alphastockimages.com/ Nick Youngson: http://nyphotographic.com/

Aimmune Therapeutics is gearing up for regulatory review of its investigational food allergy therapy AR101 following the release of new data which indicated that the drug met its primary endpoint, enabling allergic patients to tolerate approximately three to four peanut kernels.

According to the Phase 3 data, the proportion of patients who were able to tolerate a 1,000mg dose of peanut protein after receiving AR101 for around nine months of treatment was “significantly higher” compared to placebo.

Allergy Therapeutics' adjuvanted birch allergoid drug shocks with Phase 3 failure

UK-based biotech firm Allergy Therapeutics has been left disappointed after it became evident that its adjuvanted birch allergoid product failed its primary endpoint in the treatment of birch-pollen induced seasonal allergic rhinitis.

Newly revealed Phase 3 data indicated that the drug “did not show a statistically significant difference between active and placebo arms”, with trial participants failing to achieve an adequate combined symptom medication score averaged over the peak birch pollen season.

FDA accepts biologics license application for MSD’s allergy immunotherapy drug

MSD (NYSE: MRK) has announced that the US Food and Drug Administration has accepted for review the biologics license application for MK-8237, its sublingual allergy immunotherapy (SLIT) tablet for house dust mite allergies.

This application heavily draws on two Phase III clinical trials, involving more than 4,000 patients, which evaluated the efficacy and safety of MK-8237 in house dust mite-induced allergic rhinitis with or without conjunctivitis.

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Asthma & COPD

Lane Earl Cox wins allergy blood test account

Healthcare advertising agency Lane Earl & Cox has won the account to promote an allergy blood test product from diagnostics company Phadia.

ImmunoCap is a blood test which identifies specific allergens for patients with suspected allergic symptoms. Confirming atopy (allergic hypersensitivity) together with identifying the specific allergens enables better management of a wide range of common diseases including asthma, rhinitis and eczema.

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