Pharmaceutical Technology

MAY 24, 2023

Innoviva has snagged a win for its bacterial pneumonia drug Xacduro (durlobactam sodium + sulbactam) with a US Food and Drug Administration FDA approval for use in patients of ages 18 or older. The FDA approval stemmed from results from Entasis’ Phase III Attack trial (NCT03894046).

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Pharmaceutical Technology

MARCH 21, 2023

FDA and EMA decisions In January, the European Commission (EC) approved Roche’s Xofluza (baloxavir marboxil) to prevent and treat influenza in children ages one year and older. Regulatory decisions by the FDA and EMA for select therapies from late January to late February and the CMOs contracted to manufacture the therapies.

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Pharmaceutical Technology

APRIL 6, 2023

The US Food and Drug Administration (FDA) has released the fourth and final chapter in a series of guidance documents designed to support patient-focused drug development. The guidance also touched upon clinical trial design elements that must be explained, described, or rationalised to the FDA.

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Pharmaceutical Technology

MAY 23, 2023

The US Food and Drug Administration (FDA) has granted Centessa Pharmaceuticals’ activated Protein C (APC) inhibitor SerpinPC a fast track designation for treating haemophilia B. The FDA’s fast track designation is designed to speed up the regulatory process to allow faster drug development and review to fill unmet needs.

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Pharmaceutical Technology

MAY 15, 2023

If approved, the therapy could become the first FDA-approved gene transfer therapy for the condition. The FDA will assess the drug’s approval before its Prescription Drug User Fee Act (PDUFA) date on 29 May 2023. She said, “I wish the data were more persuasive”.

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Pharmaceutical Technology

MAY 9, 2023

After the FDA rejected an accelerated approval bid in January, Eli Lilly has returned with topline data proving that donanemab may be an effective alternative to Eisai’s Leqembi (lecanemab) in treating Alzheimer’s disease. The FDA approved Biogen’s Aduhelm (aducanumab) for treating Alzheimer’s disease in June 2021.

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Pharmaceutical Technology

MAY 9, 2023

After the FDA rejected an accelerated approval bid in January, Eli Lilly has returned with topline data proving that donanemab may be an effective alternative to Eisai’s Leqembi (lecanemab) in treating Alzheimer’s disease. The FDA approved Biogen’s Aduhelm (aducanumab) for treating Alzheimer’s disease in June 2021.

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Pharmaceutical Technology

MAY 9, 2023

New York-based Eyenovia has announced an FDA approval for Mydcombi (tropicamide and phenylephrine hydrochloride), the first ophthalmic spray for mydriasis or pupil dilation. The company will provide further updates on Mydcombi and its ongoing development programs and partnerships during its scheduled Q1 2023 update conference call on May 11.

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Pharmaceutical Technology

MAY 3, 2023

The US Food and Drug Administration (FDA) has granted Tenaya Therapeutics’ gene therapy TN-201 a fast track designation for the treatment of myosin binding protein C3 (MYBPC3)-associated hypertrophic cardiomyopathy (HCM). In January 2023, Tenaya announced FDA clearance for its Investigational New Drug (IND) application for TN-201.

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Pharmaceutical Technology

JUNE 2, 2023

While Leqembi was awarded an accelerated approval in January 2023, a decision on a traditional approval is expected by 6 July. The FDA will then consider the results of the committee for an approval decision in the following weeks. Clinical investigators commonly use registries to gather information on patient outcomes.

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Pharmaceutical Technology

APRIL 20, 2023

Following a tumultuous development cycle, DBV Technologies will now have to conduct an additional safety study of its peanut allergy Viaskin patch in toddlers ages 1–3 years, based on written correspondence from the US Food and Drug Administration (FDA). In March 2023, the company announced the screening of the trial’s first patient.

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Pharmaceutical Technology

APRIL 18, 2023

This news follows the treatment’s FDA approval on 10 March, making it the first-approved Rett Syndrome treatment in the US. The FDA approved the drug based on positive Phase III data from the Lavender trial. We have worked hard to make Daybue available as quickly as possible following FDA approval.”

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Pharmaceutical Technology

MAY 17, 2023

The US Food and Drug Administration (FDA) has awarded an orphan drug designation to Intercept Pharmaceuticals’ fixed-dose combination of obeticholic acid and bezafibrate for the treatment of primary biliary cholangitis. Data from the analyses will be used for a potential end-of-Phase II study meeting with the FDA.

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Pharmaceutical Technology

MAY 26, 2023

The FDA has flagged this issue as pharmacies selling prescription drugs illegally have proliferated over the years. The US Food and Drug Administration (FDA commissioner Dr. Robert Califf says, “The illegal sale of prescription drug stimulants online puts Americans at risk and contributes to potential abuse, misuse, and overdose.”

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Pharmaceutical Technology

JANUARY 6, 2023

The alleged actions violated the Hatch-Waxman Act, formally known as the “Drug Price Competition and Patent Term Restoration Act of 1984,” which allows generic manufacturers to market their generic versions of previously approved generic medications. These actions allegedly led to the extension of Novartis’ patents.

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Pharmaceutical Technology

FEBRUARY 6, 2023

In the midst of tough predictions for 2023 due to inflation and a difficult funding environment, Pliant Therapeutics closed an oversubscribed $287.5 Leading up to 2023, experts have said a company’s financial wellbeing may depend on its economic position when the market shifted. The FDA approved both drugs in 2014.

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Pharmaceutical Technology

MARCH 22, 2023

The European Commission plans to launch its revised EU pharmaceutical package in Q1 2023 to ease drug shortages,” she says. As the COVID-19 pandemic continues to take its toll on businesses worldwide, it’s time to look for new ways to create value, prepare for the future, and remain competitive in the ever-changing landscape.

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Pharmaceutical Technology

JANUARY 15, 2023

In the first 2023 edition of the CMO Moves monthly series , Pharmaceutical Technology explores recent news stories on regulatory and reimbursement decisions in different countries, and the companies linked to their success and failures. FDA expands approval labels. Source: GlobalData Pharmaceutical Intelligence Center.

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Pharmaceutical Technology

MAY 1, 2023

After a US Food and Drug Administration (FDA) Vaccines and Related Biological Products Advisory Committee (VRBPAC) Advisory Committee (AdCom) meeting in March 2023 voted unanimously in support of GSK’s respiratory syncytial virus vaccine, the odds for an approval have increased.

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Pharmaceutical Technology

APRIL 21, 2023

On March 29, 2023, the US Food and Drug Administration (FDA) granted approval that made Narcan the opioid treatment drug to be sold without a prescription. We highlight the most impactful emerging technologies, as well as the industry, regulatory, and macroeconomic factors that influence growth prospects.

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Pharmaceutical Technology

MAY 22, 2023

The drug’s supply is predicted to remain limited until late 2023. Amidst these shortages, Astellas Pharma’s Veozah (fezolinetant) has recently entered the market in the US for vasomotor symptoms caused by menopause on May 15, after an FDA approval. Serious shortage protocols are issued to manage medicine supply issues in the UK.

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Pharmaceutical Technology

MARCH 29, 2023

AlgoTx remains on track to start enrolling subjects of a Phase II study of its compound ATX01 for the rare condition erythromelalgia in Q2 2023, says CEO Stéphane Thiroloix. In June 2020, the FDA gave ATX01 an orphan drug designation in erythromelalgia.

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