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CMO Moves: Regulatory catalysts for drug manufacturing-December

Pharmaceutical Technology

In this last 2022 edition of the series, which started in June , Pharmaceutical Technology is tracking major trial announcements and decisions by regulators and reimbursement agencies that have occurred since mid-October, as well as their potential impact on manufacturing plans. Iomab-B met the durable complete remission endpoint.

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Biovectra to Build First mRNA Vaccine and Drug Manufacturing Plant in Canada

XTalks

Canadian pharma and biotech contract development and manufacturing organization (CDMO) Biovectra has announced plans for building one of the first state-of-the-art mRNA vaccine and biomanufacturing facilities in Canada. Additional production would be performed at other facilities for final packaging. million, respectively.

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Thursday pharma headlines

World of DTC Marketing

Amgen CEO Bob Bradway racked up a 2018 pay package of $18.6 regulators knew about reports of suicidal behavior in men taking the anti-baldness treatment Propecia when they decided not to warn consumers of those potential risks in a 2011 update of the popular drug’s label. million while the company’s pipe line falters.

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Health Canada consults on transition of interim order drugs, vaccines, and medical devices to permanent approval pathways

Pharma in Brief

Any authorization for drugs, vaccines, and medical devices issued pursuant to the interim orders are also set to terminate when the respective interim order expires or is withdrawn. Drugs and Vaccines. Both interim orders are set to expire 1 year after they were issued, or sooner if withdrawn by the Minister.

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Brazil: untapped market for big pharma manufacturing

Pharmaceutical Technology

Brazilian pharma production sites are involved in Covid-19 vaccine and therapy manufacture. Oswaldo Cruz Foundation will package the drug in its facility in Rio de Janeiro before supplying it to the Brazilian public health system; the company is also involved in clinical trials for the drug’s possible use as Covid-19 prophylaxis.

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CMO Moves: Regulatory Catalysts for Drug Manufacturing-November

Pharmaceutical Technology

These contracts involve the manufacturing of biological and small molecule active pharmaceutical ingredients (APIs), parenteral manufacturing and packaging, and other manufacturing-related tasks. Following similar decisions by the American and European regulators, Swissmedic approved Pfizer/BioNTech’s bivalent Comirnaty booster.

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Leading freeze-drying systems suppliers for the pharmaceutical industry

Pharmaceutical Technology

Pharmaceutical and biotechnology industries widely use freeze-drying systems to protect vaccines, antibodies, antibiotics such as penicillin, blood plasma, proteins, enzymes, hormones, viruses, and bacteria from heat and minimise their biological activity. The process eliminates the disadvantages of conventional drying methods or freezing.