Pharmaceutical Technology

DECEMBER 12, 2022

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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Manufacturing Drugs Packaging Packaging 147

Pharma Times

OCTOBER 27, 2023

The new principles will remove the regulatory burden for MLMD manufacturers - News - PharmaTimes

Regulation 152

Regulation Development Manufacturing 152

pharmaphorum

JUNE 10, 2022

If you work in pharma, the chances are you’re no stranger to the United States Food and Drug Administration, or FDA, which regulates pharmaceuticals. While the FDA is responsible for regulating both drugs and devices, they’re handled through completely different processes in different parts of the agency.

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Regulation Production Life Science Drugs 133

Bio Pharma Dive

OCTOBER 13, 2020

The biotech won't be able to start human testing of an experimental Huntington's disease treatment until regulators see more manufacturing data.

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Gene Therapy Gene Regulation Manufacturing 198

Pharmaceutical Technology

NOVEMBER 30, 2022

However, efficiently manufacturing the drug represents another barrier to cross before realizing the full revenue potential then successfully. Each month, Pharmaceutical Technology takes a look at recent decisions taken by regulatory and reimbursement agencies and identifies the key manufacturing players that can be impacted by them.

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pharmaphorum

MARCH 16, 2021

European regulators questioned the integrity of early batches of Pfizer/BioNTech’s mRNA vaccine, although the matter was resolved before approval, according to information leaked online following a cyberattack. The post Regulators questioned integrity of Pfizer/BioNTech vaccine, leaked files show appeared first on.

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Regulation Vaccine Vaccination RNA 138

Pharmaceutical Technology

SEPTEMBER 8, 2022

Good Therapeutics focuses on the development of PD-1-regulated IL-2 drugs that are based on innovative conditionally active drug technology. With the takeover, Roche will attain rights to a conditionally active, PD-1-regulated IL-2 programme of Good Therapeutics.

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Regulation Development Manufacturing Drugs 278

BioPharma Reporter

AUGUST 22, 2024

The US regulator has confirmed a delay to the approval of linvoseltamab while a manufacturing issue is resolved with a third-party provider.

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Manufacturing FDA Approval Regulation Drugs 98

pharmaphorum

MARCH 22, 2022

In this article, Ben Hargreaves asks whether there is particular potential for the technologies to revolutionise staff training and reduce costs in pharma manufacturing. The importance of manufacturing. the streamlining of pharma manufacturing in the 21st century. Taking manufacturing to the next level.

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Manufacturing Production Contamination Gene Therapy 137

AuroBlog - Aurous Healthcare Clinical Trials blog

OCTOBER 3, 2024

The Central Drugs Standard Control Organisation (CDSCO) has released a list of 59 drug samples declared as Not of Standard Quality (NSQ) during the month of August, with samples of drugs labelled as manufactured by some of the major companies failing the quality test. The State drug regulators have reported 11 NSQs to the CDSCO […]

Drugs 187

Drugs Regulation Manufacturing Clinical Trials 187

STAT News

JANUARY 9, 2023

Cough medicine tainted with ethylene glycol that killed at least 19 children in Uzbekistan in late December 2022 has once again revealed lax oversight and regulation of pharmaceutical companies based in India. That preventable tragedy, which involves products made by Marion Biotech, based in Noida, India, echoes earlier cases.

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Manufacturing Containment Regulation Medicine 122

Fierce Pharma

JULY 15, 2024

It's no secret that cell and gene therapies have faced manufacturing hurdles as the advanced medicines have become increasingly popular in recent years. | It's no secret that cell and gene therapies have faced manufacturing hurdles as the advanced medicines have become increasingly popular in recent years.

Gene Therapy 125

Gene Therapy Gene Regulation Manufacturing 125

AuroBlog - Aurous Healthcare Clinical Trials blog

AUGUST 29, 2024

The Central Drugs Standard Control Organisation (CDSCO) has released a list of 70 drug samples declared as Not of Standard Quality (NSQ), with samples of drugs labelled as manufactured by some of the major companies failing the quality test.

Drugs 183

Drugs Regulation Manufacturing Clinical Trials 183

Drug Patent Watch

DECEMBER 10, 2024

The pharmaceutical and biotechnology industries are heavily regulated, and navigating these regulations can be a significant challenge for companies, especially those with limited experience. Contract Development and Manufacturing Organizations (CDMOs) play a crucial role in helping companies overcome these regulatory hurdles.

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Compliance Manufacturing Production Regulation 98

AuroBlog - Aurous Healthcare Clinical Trials blog

DECEMBER 12, 2022

The Subject Expert Committee (SEC) for Reproductive and Urology, which advices the nation’s drug regulator on clinical studies and approvals, has recommended approval for the State-run HLL Lifecare Ltd to manufacture and market graphene condom, the next generation thinner; and stronger condom that is expected to improve the acceptability of the (..)

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Regulation Manufacturing Production Marketing 189

AuroBlog - Aurous Healthcare Clinical Trials blog

MARCH 16, 2023

The Central Drugs Standard Control Organisation (CDSCO) has approved two more Medical Device Testing Laboratories (MDTL) to carry out tests or evaluation of a medical device on behalf of the manufacturers under the provisions of the Medical Devices Rules (MDR), 2017.

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Regulation Manufacturing Drugs Clinical Trials 188

AuroBlog - Aurous Healthcare Clinical Trials blog

NOVEMBER 24, 2022

The Central Drugs Standard Control Organisation (CDSCO) has approved four more Medical Device Testing Laboratories (MDTL) to carry out tests or evaluation of a medical device on behalf of the manufacturers under the provisions of the Medical Devices Rules, 2017.

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Regulation Manufacturing Drugs Clinical Trials 187

AuroBlog - Aurous Healthcare Clinical Trials blog

JULY 11, 2023

The Delhi High Court has granted ten days’ time to the Government of India and the nation’s drug regulator to file a counter affidavit on the petitions filed by almost 28 pharma companies against the order prohibiting manufacturing, distribution and sale of 14 FDCs licensed prior to the year 1988, in the beginning of June. […]

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Pharma Companies Licensing Licensing Sales 186

AuroBlog - Aurous Healthcare Clinical Trials blog

MARCH 12, 2023

The Subject Expert Committee (SEC), which advises the drug regulator on the approval of drugs and clinical trials of antimicrobial and antiviral drugs, has recommended waiver of phase III clinical trial on Emcure Pharmaceuticals’ application for manufacturing and marketing of HIV drug doravirine 100 mg and its bulk drug in the country.Merck Sharp and (..)

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Clinical Trials Clinical Trials Trials Drugs 184

Pharmaceutical Technology

APRIL 14, 2023

The US Food and Drug Administration (FDA) has rejected Eli Lilly’s biologic licence application (BLA) for the ulcerative colitis (UC) drug mirikizumab over manufacturing concerns. The regulator has issued a complete response letter. No concerns related to the clinical data package, safety or the medicine label.

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Manufacturing Drugs Hormones Packaging 130

Drug Patent Watch

OCTOBER 24, 2024

With the majority of generic drugs manufactured overseas, ensuring compliance with regulatory standards is crucial. This article delves into the complexities of generic drug regulation, highlighting the challenges faced by the U.S. Food and Drug Administration… Source

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Generic Drugs Drugs Compliance Regulation 100

Pharmaceutical Technology

OCTOBER 26, 2022

Nano-based delivery systems are on the rise, as they enable manufacturers to deliver therapeutic agents to specific targeted tissue in a more controlled manner. Regulations and guidelines for nanopharmaceuticals are still relatively in their infancy, including for cleaning processes and the prevention of cross-contamination.

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Manufacturing Drug Delivery Systems Contamination Drug Delivery 130

XTalks

JULY 30, 2024

By focusing on these proactive measures, EU regulations aim to prevent Salmonella contamination before poultry products reach consumers. The contrasting approaches to Salmonella control in the US and EU highlight the importance of evaluating food safety regulations.

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Regulation Contamination Production Manufacturing 98

Bio Pharma Dive

SEPTEMBER 20, 2023

The drug regulator has twice rejected Alvotech’s biosimilar due to manufacturing issues with a plant in Europe.

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Regulation Manufacturing Drugs 156

AuroBlog - Aurous Healthcare Clinical Trials blog

JUNE 11, 2023

The drug regulator, in a drug alert issued, said that a batch of Typbar, manufactured by Bharat Biotech International Ltd in Genome Valley in Hyderabad, Telangana, failed […]

Vaccine 180

Vaccine Vaccination Genome Genomics 180

STAT News

OCTOBER 25, 2022

The antitrust regulator in Spain has fined Merck approximately $39 million for preventing a competitor from marketing a generic version of a hormonal contraceptive, the latest effort by a European government to crack down on anti-competitive practices in the pharmaceutical industry. Continue to STAT+ to read the full story…

Regulation 98

Regulation Hormones Manufacturing Production 98

BioPharma Reporter

OCTOBER 5, 2023

Sharp, a commercial pharma packaging and clinical trial supply services firm, has acquired Berkshire Sterile Manufacturing (BSM), a Massachusetts-based fill finish contract development and manufacturing organization (CDMO).

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Manufacturing Pharma Packaging Packaging Packaging 105

BioSpace

OCTOBER 1, 2023

Eli Lilly’s Biologic License Application for its monoclonal antibody lebrikizumab was denied by the regulator after issues were found at a third-party contract manufacturing organization.

Manufacturing 91

Manufacturing Contract Manufacturing Licensing Licensing 91

Pharmaceutical Technology

APRIL 21, 2023

While the FDA sent Lilly a complete response letter detailing issues pertaining to the proposed manufacturing of mirikizumab, the regulator raised no concerns about the clinical data package or label for the medicine. However, that will depend on how quickly Lilly can address the regulator’s manufacturing concerns.

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XTalks

MAY 3, 2024

Challenges and Need for Vigilance: Despite explicit cooking instructions on labels, the persistence of Salmonella -related illnesses underscores the necessity for strict regulations. For example, last month, Trader Joe’s recalled specific fresh basil packages from 29 states following a Salmonella outbreak that affected 12 individuals.

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Regulation Production Contamination Packaging 103

Fierce Pharma

SEPTEMBER 14, 2023

Efforts from regulators and manufacturers have brought the U.S. While there's certainly more work to do, the U.S. supply of cisplatin back to nearly 100% of pre-shortage levels, according to the White House. The moves are “greatly alleviating the shortages of carboplatin,” too, the White House said.

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Manufacturing Regulation Drugs 95

BioPharma Reporter

APRIL 18, 2024

When imagining a pharmaceutical manufacturing facility, many picture it in a vast rural setting, offering ample space for large-scale operations.

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Manufacturing Regulation Marketing 104

Pharmaceutical Technology

JULY 25, 2022

With decreasing margins on the horizon, pharma manufacturers have long shown an interest in specialty generics, which is only expected to rise in the future. Despite this, specialty generics are expected to be the domain of a handful of companies with the necessary manufacturing capabilities and legal backing needed for entering the market.

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Drugs Manufacturing Production Marketing 298

Pharmaceutical Technology

NOVEMBER 22, 2024

The UK’s proposed regulations would provide the legal framework for POC manufacturing of cell therapies, including quality assurance.

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Production Regulation Manufacturing 130

BioPharma Reporter

JANUARY 10, 2023

Catalent is to support the manufacture of Sarepta Therapeutics' gene therapy candidate for the treatment of Duchenne muscular dystrophy (DMD).

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Gene Therapy Manufacturing Gene Regulation 118

Pharmaceutical Technology

SEPTEMBER 4, 2024

Despite the best efforts of pharmaceutical manufacturers and regulators to improve the security and traceability of drug products, counterfeits continue…

Regulation 130

Regulation Manufacturing Production Drugs 130

XTalks

JUNE 12, 2023

Bristol Myers Squibb (BMS), a multinational pharmaceutical company based in New York City, has announced that its new state-of-the-art cell therapy manufacturing facility in Devens, Massachusetts, has received approval for commercial production from the US Food and Drug Administration (FDA).

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Manufacturing Gene Therapy FDA Approval Gene 95