World of DTC Marketing

FEBRUARY 21, 2022

Pfizer and Merck have chosen to designate a select few generic manufacturers to produce cheaper versions of their drugs through the Medicines Patent Pool (MPP). The post The drug industry continues to dare regulation appeared first on World of DTC Marketing.com. ” More checks from PhRMA to politicians are coming up.

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Regulation Drugs Bioequivalency Pharmacy 218

Fierce Pharma

JUNE 28, 2023

Eton Pharmaceuticals’ dehydrated alcohol injection didn’t pass muster with the FDA, instead receiving a complete response letter (CRL) raising flags the company believes are “addressable.” | The dehydrated alcohol injection was turned down due to problems with its chemistry manufacturing and controls, issues which the company believes are addressable, (..)

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Pharmaceutical Technology

JULY 29, 2022

Pfizer (New York, New York) and Moderna’s (Cambridge, Massachusetts) Omicron-specific Covid-19 vaccines are in late-stage development, have demonstrated good efficacy against the variant and will likely be available to the public later this year to provide an additional booster and increase demand for injectable manufacturing.

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Pharmaceutical Technology

MARCH 30, 2023

The US FDA has revealed its detailed budget proposal for FY2024, which would require pharma companies to name their active pharmaceutical ingredient (API) suppliers, restart President Biden’s Cancer Moonshot, inject cash into amyotrophic lateral sclerosis (ALS) research, and enforce stricter rules around manufacturing, recalls, and shortages.

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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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Pharmaceutical Technology

DECEMBER 20, 2022

Drug manufacturers around the world now have key information needed to consider and more broadly adopt this technology, which is designed to standardize operations across different sites and installations. The collaborative spirit arising between pharmaceutical and biotechnology companies is leading to a new rapport with regulators, as well.

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XTalks

FEBRUARY 26, 2024

Key developments in food regulations in 2024 are expected, focusing on safety, transparency and public health. For stakeholders in the food industry, understanding and adapting to these regulations is not just a matter of compliance but a strategic imperative for business success.

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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 105

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 98

AuroBlog - Aurous Healthcare Clinical Trials blog

MAY 7, 2024

The national drug regulator has withdrawn the powers delegated to the State and Union Territory (UT) Licensing Authorities to issue No Objection Certificates (NOCs) for manufacture of unapproved, banned or new drugs solely for export purpose, asking the industry to file fresh applications with the central authority online from May 15.

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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

Pharma in Brief

AUGUST 9, 2021

On July 31, 2021, Health Canada published a Notice of Intent outlining its plan to amend the Food and Drug Regulations ( FDR ) and the Medical Devices Regulations in the spring of 2022. Manufacturing Controls. Food and Drug Regulations , C.R.C., Medical Devices Regulations , SOR/98-282. Risk Management Plan (RMP).

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Regulation Drugs Manufacturing Production 98

Pharma in Brief

DECEMBER 3, 2023

This year marks the 30-year anniversary of the Patented Medicines (Notice of Compliance) Regulations ( Regulations ), introduced in 1993 to prevent patent infringement by linking the regulatory approval of generic or biosimilar drugs with the patent rights of innovators. Evolution of the Regulations Coming into force (1993–1997).

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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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Fierce Pharma

AUGUST 2, 2023

FDA reads like a checklist of what not to do when the regulator pays a visit to your manufacturing facility. | Intas Pharmaceuticals’ new warning letter from the U.S. The FDA handed Intas a five-observation write up after inspecting the company’s Sanand, India, production plant from November 22 to December 2, 2022.

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Manufacturing Regulation Production 97

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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Pharmaceutical Technology

APRIL 26, 2023

The conceptualisation, development and manufacturing of primary packaging in the pharmaceutical industry require a meticulous and multi-disciplinary approach to ensure that the products meet the highest standards of safety and efficacy.

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Packaging Packaging Manufacturing Development 130

Pharma Times

OCTOBER 27, 2023

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

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Regulation Development Manufacturing 121

Fierce Pharma

JULY 12, 2023

drug regulator certainly could have been worse for the company. Following an inspection of Lupin’s Pithampur Unit-2 manufacturing facility in Madhya Pradesh, India, from March 21 to March 29, the FDA handed the company an inspection with a classification of Voluntary Action Indicated. .

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FDA Law Blog

DECEMBER 3, 2023

As part of this change, the Coverage Gap Discount Program (CGDP), a program that has existed since 2011, will sunset on December 31, 2024, and be replaced by the Medicare Part D Manufacturer Discount Program (the “Discount Program”). CMS will send the final manufacturer invoice for discount liabilities accrued by then on April 30, 2028.

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BioPharma Reporter

MARCH 11, 2024

million grant to help the company develop a âminiaturized and autonomousâ cell therapy manufacturing platform using deep tech. Austian start-up Sarcura has secured a â1.7

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Manufacturing Development Regulation Marketing 97

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

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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Bio Pharma Dive

MAY 2, 2022

The regulator cited concerns around single-country trials in turning back Hutchmed's pancreatic cancer treatment, while manufacturing issues held up Junshi and Coherus' throat cancer medicine.

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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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Pharmaceutical Technology

FEBRUARY 3, 2023

Additionally, OSD manufacturing approaches are well developed, with processes that ensure a repeatable distribution of ingredients, uniformity in dissolution, and bioavailability, which verify that the drug product is safe and effective. Compared to other dosage forms, tablets are simpler to manufacture, package, and transport.

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Contamination Manufacturing Containment Production 130

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…

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Regulation Hormones Manufacturing Production 98

FDA Law Blog

MARCH 24, 2024

By Faraz Siddiqui — As drug manufacturers battle the Health Resources and Services Administration (“HRSA”) in federal courts over the role of 340B contract pharmacies, an Eighth Circuit decision to uphold a 2021 Arkansas law may render those cases inconsequential in that state. Code Ann. § 23-92-604(c)(1), (2) (Act 1103).

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Pharmacy Manufacturing Drugs Regulation 59

BioPharma Reporter

MAY 15, 2024

Before the industry is set to arrive in San Diego for Bio International 2024, we spoke with Dr. Harald Oberegger, global head business development at Novartis Contract Manufacturing.

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FDA Law Blog

MARCH 31, 2024

Gibbs — On March 21, 2024, the House Energy and Commerce held a subcommittee hearing titled “Evaluating Approaches to Diagnostic Test Regulation and the Impact of the FDA’s Proposed Rule.” By Ana Loloei & Jeffrey N. FDA, which was not invited to participate, would surely have concurred.

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Drug Discovery World

SEPTEMBER 5, 2023

In the eleventh eBook of the Hamilton series ‘Analytical Methods for Viral Vector Development and Manufacturing in Gene Therapy’, we learn about: Gene therapy: history, viral vectors and the role of CDMOs Automation of analytical assays during viral vector development and manufacturing The solutions that Hamilton offers to customers working (..)

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BioPharma Reporter

SEPTEMBER 19, 2023

The contract development and manufacturing organization (CDMO) Fujifilm Diosynth Biotechnologies has completed a UK manufacturing facility for the production of advanced therapies including viral gene therapies, oncolytic viruses and viral vaccines for use in clinical trials.

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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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BioSpace

APRIL 22, 2024

The regulator on Monday slapped Abeona Therapeutics with a Complete Response Letter for its investigational cell therapy pz-cel due to chemistry, manufacturing and controls issues.

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BioPharma Reporter

MARCH 20, 2024

Lonza is set to acquire a large-scale manufacturing site from Roche-owned U.S. giant Genentech for $1.2 billion.

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Manufacturing Regulation Marketing 98

BioPharma Reporter

MAY 21, 2024

million to take its solution for automating cell therapy manufacturing to the next stage of development. Life science startup Limula has raised $6.8

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Pharmaceutical Technology

MAY 26, 2023

John Hertig, the president of the board of directors for the nonprofit Alliance for Safe Online Pharmacies (ASOP) Global says, “Counterfeit products sold by illegal online pharmacies often are manufactured in unsafe conditions, contain little or no active ingredients and/or are manufactured using dangerous and sometimes deadly substances.”

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