Camargo

DECEMBER 9, 2020

Biopharma and manufacturing company Alkermes was recently able to participate in a remote document review for its ALKS 3831 product. The pharma industry has had meetings with the FDA for new drugs, biologics, and devices for decades. GDUFA has changed this picture, at least for complex drug products.

Development 140

Development Production Drugs FDA Approval 140

FDA Law Blog

APRIL 8, 2024

This year’s report noted that CDER’s Drug Product Catalog contains over 140,000 entries, the same amount as OPQ listed in 2022. Readers also saw that that the Center’s manufacturing Site Catalog remains steady at more than 4,800 entries, the same number we found in the 2022 State of Pharmaceutical Quality report.

Manufacturing 59

Manufacturing Compliance Drugs Generic Drugs 59

Drug Channels

MARCH 15, 2022

Licenses for our DCI reports are regularly purchased by nearly every company involved in the drug channel: pharmaceutical manufacturers, wholesalers, pharmacists, pharmacy owners, hospitals, buyers, benefit managers, managed care executives, policy analysts, investors, consultants, and more.

Pharmacy 83

Pharmacy Drugs Marketing Licensing 83

pharmaphorum

AUGUST 24, 2020

The conference is proudly chaired by Lynne Ensor, Vice President, Technical, Parexel International as a 21-year veteran of the FDA, her areas of expertise include biopharmaceutical sterile product manufacturing and testing, pharmaceutical microbiology, pharmacy compounding, and regulatory policy development. in Biology and Ph.D.

Contamination 52

Contamination In-Vitro Production Containment 52

FDA Law Blog

AUGUST 17, 2023

Vanda requested that FDA revoke the approval of Apotex’s and Teva’s generic versions of Hetlioz on the grounds that the generic tasimelteon products did not meet the statutory “same labeling” requirement for generic drugs found in 21 U.S.C. § 355(j)(2)(A)(v). FDA regulations, at 21 C.F.R.

Generic Drugs 40

Generic Drugs Production Drugs Manufacturing 40

The Pharma Data

DECEMBER 28, 2020

This further highlights Amphastar’s considerable abilities to bring complex generic drugs to the market, and more specifically, our strong peptide capabilities.” sales of brand products containing glucagon for injection, 1 mg, were approximately $306 million for the 12 months ended September 30, 2020. Company Information.

Bioequivalency 52

Bioequivalency Production Sales Marketing 52

Drug Channels

FEBRUARY 23, 2021

Despite these responses, more than half of payers believe that cost containment strategies should not limit patients’ ability to receive access to appropriate care. It illustrates how a 340B hospital can earn three times what the manufacturer earns from a provider-administered product. See page 15 (reproduced below). Click to Enlarge].

Pharmacy 52

Pharmacy Drugs Production Generic Drugs 52

The Pharma Data

DECEMBER 17, 2020

In addition, TLC is preparing for scale-up production of TLC590, as for complex lipid products, the manufacturing process and batch size used in pivotal clinical trials and New Drug Application submission must be the same as future commercial batches. Cautionary Note on Forward-Looking Statements. Source link.

Clinical Trials 40

Clinical Trials Clinical Trials Trials Containment 40

The Pharma Data

JANUARY 17, 2021

The Company will continue to leverage its scientific expertise and operations in Europe and North America for product development and optimization while it plans to add significant commercial experience in the fields of manufacturing, distribution, marketing and sales. About XPhyto Therapeutics Corp. XPhyto Therapeutics Corp.

Production 40

Production Development Drug Delivery Drugs 40

FDA Law Blog

JANUARY 11, 2022

Teva , the generic industry has been waiting with bated breath to see whether the section viii carve-out (and thus skinny-labeled generic drugs) will survive. Hikma , the generic industry can have some hope. Koblitz — Since the August 2021 decision in GSK v.

FDA Approval 52

FDA Approval Production Branding Drugs 52

FDA Law Blog

JANUARY 11, 2022

Teva , the generic industry has been waiting with bated breath to see whether the section viii carve-out (and thus skinny-labeled generic drugs) will survive. Hikma , the generic industry can have some hope. Koblitz — Since the August 2021 decision in GSK v.

FDA Approval 52

FDA Approval Production Branding Drugs 52

XTalks

AUGUST 2, 2023

Most of the company’s revenue comes from the manufacture and sale of biopharmaceutical products. Comirnaty was first approved by the US Food and Drug Administration (FDA) in August 2021 for individuals over the age of 16. It contains the antiviral medications nirmatrelvir and ritonavir. billion the drug generated in 2021.

Sales 98

Sales Manufacturing FDA Approval Life Science 98

Pharma in Brief

APRIL 25, 2021

salt forms) to be listed on the patent register and are intended to balance Proposed FDR Amendments [2] published on March 30, 2019 which allow generic manufacturers to file an ANDS for an alternative form of a medicinal ingredient in comparison to the CRP. Proposed FDR Amendments Create Imbalance in Linkage Regime.

Regulation 98

Regulation Medicine Generic Drugs Containment 98

Druggist

MARCH 25, 2021

Do generic, and branded drugs produce exactly the same effect? . Both contraceptives contain the same active ingredient: desogestrel (75 micrograms), a female sex hormone (synthetic progestogen). In terms of prescribing, both contraceptives are regarded as the same drug. . Cerelle vs Cerazette: are they the same?

Branding 98

Branding Bioequivalency Pharmacy Generic Drugs 98

XTalks

JUNE 16, 2023

This means patients are being given alternate drugs that could have more severe side effects, or instead of a combination, they may be only given one drug that is available. Medicines for Europe said the supply issues were evidence of the damaging effects of European cost-containment measures.

Drugs 98

Drugs Manufacturing Clinical Supply Chain Clinical Trials 98

The Pharma Data

JANUARY 27, 2021

Construction of commercial drug manufacturing facility in Germany. Development of oral biosensor and contract development & manufacturing. Psychedelic transdermal and sublingual drug formulation development. Four clinical studies in neurological indications in 2021.

Drugs 52

Drugs Manufacturing Drug Delivery Production 52

Druggist

OCTOBER 13, 2020

Truvada is a brand name of a combination drug, which contains two antiviral medicines: emtricitabine and tenofovir disoproxil. This post will cover the use of Truvada and its generic form for PrEP. One important message to take away is that Truvada and equivalent generic drugs are not 100% effective.

Generic Drugs 98

Generic Drugs Pharmacy Branding Doctors 98

The Pharma Data

MAY 4, 2021

Following the completion of the spin-off of the Upjohn Business (4) in the fourth quarter of 2020, Pfizer now operates as a focused innovative biopharmaceutical company engaged in the discovery, development, manufacturing, marketing, sales and distribution of biopharmaceutical products worldwide. down 7%, which reflects relatively stable U.S.

Vaccination 40

Vaccination Vaccine Production Sales 40

Pharma in Brief

AUGUST 9, 2021

Terms and conditions would be imposed after discussions with the manufacturer and would obligate them to take steps to manage risks and resolve uncertainties. An RMP summarizes the risks of a drug and the pharmacovigilance activities and other measures that a manufacturer puts in place to monitor and manage any identified risks.

Regulation 98

Regulation Drugs Manufacturing Production 98

The Pharma Data

OCTOBER 14, 2020

About Mallinckrodt Mallinckrodt is a global business consisting of multiple wholly owned subsidiaries that develop, manufacture, market and distribute specialty pharmaceutical products and therapies. Its Specialty Generics reportable segment includes specialty generic drugs and active pharmaceutical ingredients.

Production 40

Production Branding Development Regulation 40

Pharma in Brief

JANUARY 9, 2022

Meanwhile, the Ontario Superior Court released two decisions dismissing claims made by a generic manufacturer under the Ontario and English Statutes of Monopolies , and common law causes of actions. In 2020, the FC struck down the new price calculation contained in the amendments but upheld the other impugned amendments.

Regulation 52

Regulation Manufacturing Drugs Medicine 52

XTalks

AUGUST 30, 2022

The pharmaceutical industry deals with threats such as product liability, cyberthreats, supply chain disruptions, competition from generic drugs and more. Although these leadership styles are of very different natures, they also contain some commonalities. Therefore, strategic intent is vital when making decisions.

Life Science 105

Life Science Generic Drugs Drug Delivery Compliance 105

FDA Law Blog

OCTOBER 16, 2024

There, as we explained back in July , Novartis argued that FDA’s approval of a generic ENTRESTO with indication information modified rather than simply omitted “represents a sharp departure from FDA’s statutory and regulatory mandate to require that a generic drug be the ‘same’ as its reference listed drug.”

Generic Drugs 98

Generic Drugs FDA Approval Drugs Production 98

Pharmaceutical Technology

DECEMBER 4, 2022

Also, some biosimilars contain citrate, while others like Abrilada do not. Low-concentration versions of Hadlima and Hyrimoz, produced by Sandoz, Novartis’s generic subsidiary, contain citrate. Humira can be administered via autoinjectors and syringes. All of this makes the transition less seamless, she notes. Free Report.

Marketing 262

Marketing Pharmacy Production Branding 262

Pharmaceutical Technology

JANUARY 6, 2023

In 2020, the Federal Trade Commission issued a report regarding settlements reached between brand and generic manufacturers in FY 2017 and noted that “for the first time since [FY] 2004, no settlement agreement in [FY] 2017 contains a no-[authorized generic] AG commitment.”. Gilenya legal drama.

Doctors 242

Doctors Doctor Drugs Sales 242

XTalks

SEPTEMBER 14, 2020

“Vaccine Nationalism” Could Prove the Undoing of COVID-19 Containment. In April alone, food and accommodation services had dropped by a good 42 percent, manufacturing followed with a 22.5 Continuing trends suggest the worst may be over provided the outbreak is contained over the next few months. Drugs and Vaccines.

Vaccination 92

Vaccination Vaccine Antibody Life Science 92