The Pharma Data

NOVEMBER 3, 2020

Infringement litigation against Sun Pharmaceutical was commenced in response to Sun Pharmaceutical, that has filed an Abbreviated New Drug Application with the US FDA for ZUBSOLV® in the US. is obliged to make public pursuant to the EU Market Abuse Regulation. Important events after the period.

Therapies 52

Therapies Pharmaceuticals Production Marketing 52

LifeSciVC

OCTOBER 13, 2022

This summer, approvals on both sides of the Atlantic – for beta thalassemia and cerebral adrenoleukodystrophy in the United States and for severe hemophilia A and aromatic L-amino acid carboxylase deficiency in Europe – show that regulators are likely open to green-lighting a range of emerging gene therapies. million price.

Therapies 40

Therapies Disease Treatment Marketing 40

The Pharma Data

SEPTEMBER 7, 2020

“As a global leader in neuroscience, we have been committed to bringing life-changing therapies to people living with diseases like MS for more than 75 years,” said Estelle Vester-Blokland, Global Head Neuroscience Medical Affairs, Novartis Pharmaceuticals. East Hanover, NJ: Novartis Pharmaceuticals Corp; August 2020. Atlas of MS 2013.

Therapies 52

Therapies Clinical Trials Treatment Disease 52

Agency IQ

JANUARY 12, 2024

BY AMANDA CONTI | JAN 10, 2024 9:29 PM CST Quick background: Goal dates under the Prescription Drug User Fee Act (PDUFA) The FDA collects user fees as part of an essential bargain between regulators and industry. In fact, CDER received a perfect 100% for meeting PDUFA dates for novel drugs in 2013, 2017, 2018 and 2020.

FDA 40

FDA Drugs Production Licensing 40

The Pharma Data

DECEMBER 15, 2020

Pancreatic cancer remains an area of unmet medical need, with no new approved therapies since the approval of nab-paclitaxel (Abraxane ® ) in combination with gemcitabine for first-line treatment in 2013 and Onivyde ® in combination with fluorouracil and leucovorin for second-line treatment in 2015. as well as Champions Oncology Inc.,

Clinical Trials 40

Clinical Trials Trials Treatment Therapies 40

DrugBank

AUGUST 15, 2024

To effectively navigate this ecosystem and expedite the development of new therapies, collaboration between the pharmaceutical industry and academia is proving increasingly vital. The relationship between industry and academia is evident in numerous high-level collaborations.

Drug Development 98

Drug Development Clinical Trials Drugs Therapies 98

Drug Target Review

SEPTEMBER 4, 2023

17 Drug target site Kinase targets have been addressed by the pharmaceutical industry and offer the potential for the development of new drugs in several therapeutic areas with kinases and/or phosphatases according to this report. In this assay, active compounds are discovered under physiologically relevant conditions. PE 740.238 Bryant, M.

Drugs 111

Drugs RNA DNA Disease 111

Agency IQ

AUGUST 9, 2024

This draft guideline, which was open for public comments from September 15, 2023, through March 31, 2024, aims to modernize its set of criteria for developing medicines to treat depression since the guideline has not been updated since 2013. Although the E.U.

Clinical Trials 40

Clinical Trials Regulations Trials FDA 40

The Pharma Data

MAY 15, 2023

Before joining Nestlé he served as CFO at Takeda Pharmaceuticals, one of the largest publicly listed companies in Japan, between 2013 and 2015, and CFO at Millicom, a NASDAQ listed global mobile phone operator based in Luxembourg, between 2008 and 2013. François-Xavier Roger, Chief Financial Officer of Nestlé S.A.,

Science 40

Science Doctors Government Pharmaceuticals 40

Agency IQ

JUNE 21, 2024

Commission proposes guidelines to flesh out the newly finalized Variations Regulation This week, the newly finalized Variations Regulation was published in the Official Journal of the E.U. An updated guideline implementing the changes from the new regulation is now open for public consultation until August 23, 2024.

Regulations 40

Regulations Marketing Production Vaccine 40

New Drug Approvals

SEPTEMBER 29, 2024

At CTAD, the company announced plans for a confirmatory trial, pending discussions with regulators. In January 2023, Quince put out word that it had sold Cortexyme’s legacy small molecule protease inhibitor portfolio to Lighthouse Pharmaceuticals, a company co-founded by a former Cortexyme CEO ( press release ). J Alzheimers Dis.

Small Molecule 62

Small Molecule DNA Disease Trials 62

Agency IQ

JULY 5, 2023

What we expect the EPA to do in July 2023 In this returning feature, AgencyIQ looks at public data to determine what the Environmental Protection Agency (EPA) is planning to do in the month ahead, including deadlines, meetings, events, planned regulations, comment periods, and more.

Regulations 40

Regulations Compliance International Engineering 40

Agency IQ

JANUARY 26, 2024

Though regulations guide some aspects of how expiration dates are determined, the agency has but limited power to extend those dates unilaterally. As part of current good manufacturing practice (cGMP) regulations, drugs are required to bear an expiration date determined by “appropriate stability testing,” according to 21 CFR 211.137.

Science 40

Science FDA Production Packaging 40

Agency IQ

JULY 28, 2023

DSCSA implementation – Down to the wire as a deadline draws near: The Drug Supply Chain Security Act (DSCSA) was enacted in 2013 as part of the Drug Quality and Security Act (DQSA), following several drug counterfeiting scandals in which falsified medical products entered the supply chain. That would leave 19% of staff affected by furloughs.

FDA 40

FDA Science Biosimilars Regulations 40

The Pharma Data

JANUARY 13, 2021

Lancet Respir Med 2013. Ensifentrine also activates the Cystic Fibrosis Transmembrane Conductance Regulator (“CFTR”), which is beneficial in reducing mucous viscosity and improving mucociliary clearance. Further information about this study can be found at www.clinicaltrials.gov , NCT04527471. Franciosi LG, et al., .

Hospitals 52

Hospitals Clinical Trials Therapies Treatment 52

The Pharma Data

APRIL 27, 2021

They are among the first products certified under the new European In Vitro Diagnostics Regulation (IVDR) and available as of today in countries accepting CE mark. About Roche Roche is a global pioneer in pharmaceuticals and diagnostics focused on advancing science to improve people’s lives. In 2020, Roche invested CHF 12.2

Treatment 40

Treatment Disease Pharmaceuticals Therapies 40

LifeSciVC

APRIL 27, 2023

Much of our success springs from being nimble and pragmatic on the journey: by optimizing areas we know work well and adapting to ever-changing landscapes in the capital markets, therapeutics spaces, and laws and regulations (e.g.,

Small Molecule 40

Small Molecule Computational Chemistry Engineering Clinical Development 40

The Pharma Data

NOVEMBER 4, 2020

As with much of the pharmaceutical industry, VASCEPA revenue and prescription growth have been adversely impacted by the COVID-19 pandemic. Securities and Exchange Commission Regulation G. Use of Non-GAAP Adjusted Financial Information. Included in this press release are non-GAAP adjusted financial information as defined by U.S.

Production 40

Production Trials FDA Disease 40

Agency IQ

JUNE 16, 2023

Highlights of the EPA’s Unified Agenda for Spring 2023 The Office of Management and Budget has released the Unified Agenda for Spring 2023, which outlines the regulations that agencies expect to release in 2023 and 2024. This information would be used in considering the regulation of asbestos.

Regulations 40

Regulations Compliance Production Science 40

Agency IQ

DECEMBER 15, 2023

The 174 regulations the EPA is currently working on The Environmental Protection Agency has unveiled its Fall 2023 Unified Agenda, which provides a look into the agency’s regulatory agenda for the upcoming year. The expected release dates of the agendas rarely line up exactly with the actual dates when the agency releases the regulation.

Regulations 40

Regulations Compliance Production Government 40

The Pharma Data

NOVEMBER 24, 2020

31,14 (2013): 1748-57. The company undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise. . “Germline BRCA mutations are associated with higher risk of nodal involvement, distant metastasis, and poor survival outcomes in prostate cancer.”

Treatment 52

Treatment DNA Trials Therapies 52

FDA Law Blog: Biosimilars

DECEMBER 1, 2024

The current Warning Letter was issued to a drug manufacturer in China (Tianjin Darentang Jingwanhong Pharmaceutical Co., for multiple violations observed during an inspection that occurred eight months ago. Section 704 of the Federal Food, Drug, and Cosmetic Act (“FDCA”) (21 U.S.C.

FDA 113

FDA Regulations Pharmaceuticals Drugs 113

Codon

DECEMBER 12, 2024

A drug called thalidomide, initially made by a West German pharmaceutical company called Chemie Grünenthal, was manufactured and given to patients as a mixture containing both enantiomers. In 2013, it became the only international treaty to have been ratified by every country on the planet.

DNA 103

DNA RNA Vaccine Virus 103

Drug & Device Law

FEBRUARY 15, 2024

Additionally, if applied retroactively, the revisions would impose a new duty on pharmaceutical drug manufacturers and sellers at the time the injury occurred, where none had existed before. 12-cv-244, 2013 WL 12085097, at *4 (W.D. May 9, 2013)) or wrongful death cases ( White v. 2d 277, 286 (Mich. Cartridge Co. , 804, 813 (E.D.

Production 52

Production FDA Approval FDA Compliance 52

Drug & Device Law

FEBRUARY 11, 2024

Another of our posts quoted similar concerns raised by our clients in the pharmaceutical industry as the matter was being successfully appealed to the United States Supreme Court: The Fifth Circuit’s ruling threatens to stifle pharmaceutical innovation by disrupting industry’s reasonable investment-backed expectations. FDA , 715 F.3d

FDA 59

FDA Production FDA Approval Regulations 59

Drug & Device Law

DECEMBER 29, 2023

2023) (HHS cannot force pharmaceutical manufacturers to sell unlimited amounts of prescription drugs at a discount) ( here ). Indeed, even the weird alternatives the plaintiff advocated, such as “point of sale” signs and DTC advertising (assuming these were Prop 65 remedies at all), were still FDA-regulated labeling. 4th 851 (6th Cir.

Testimonials 105

Testimonials Drugs FDA Vaccine 105

Drug & Device Law

DECEMBER 21, 2023

2023), was the Fifth Circuit’s blatantly politicized attack on the FDA’s regulation of abortion-related drugs. Bexis’ amicus efforts this year in Mallory obviously came to naught, and we’ve had our own cases on this list before (see, e.g. , 2013-2 and 2021-10 ). Takeda Pharmaceutical Co. , Luitpold Pharmaceuticals, Inc.

FDA Approval 52

FDA Approval FDA Drugs Production 52

Drug & Device Law

OCTOBER 20, 2023

LLC litigation, in which an anti-abortion group is seeking to invalidate regulatory actions taken by the FDA with regard to mifepristone , a pharmaceutical FDA-approved for use in the termination of pregnancy to ten weeks, in combination with misoprostol. 2013) (Kavanaugh, J.). FDA/Alliance for Hippocratic Medicine v. Danco Labs.,

FDA 59

FDA FDA Approval Clinical Trials Pharmaceuticals 59

Drug & Device Law

OCTOBER 10, 2023

Each claim alleges that defendants’ failure to comply with FDA’s regulations is an unfair business practice and/or causes “consumer confusion.” 2013), the court held that plaintiff could not “bring a claim that rests solely on the non-disclosure to patients of facts tied to the scope of [FDA] approval.” See Telebrands , at *8-11.

FDA Approval 59

FDA Approval FDA Pharmacy Regulations 59

Drug & Device Law

SEPTEMBER 22, 2023

in part to aid the cause of medical device and pharmaceutical manufacturers , targets in our lawsuit-obsessed country. 379r(c)(2), Carter also quickly recognized that the OTC preemption “state requirement” prong includes state law causes of action, not just state legislation or regulations. 604 (2011), and Mutual Pharmaceutical Co.

Drugs 105

Drugs Regulations Production FDA Approval 105

Drug & Device Law

AUGUST 31, 2023

The court dismissed the design-defect claim as pleaded, holding it impliedly preempted under Mutual Pharmaceutical Co. 472 (2013), because “[i]t would be impossible for [the manufacturer] to comply with both its state duty to change the composition of [the biologic] and its duty under 21 C.F.R. Bartlett , 570 U.S. Courts are divided.

FDA Approval 59

FDA Approval FDA Production Pharmaceuticals 59

Drug & Device Law

JULY 31, 2023

2003), an Internal Revenue Service regulation, excluded liability for “product” refund, repair or replacement. Medicis Pharmaceutical Corp. , Armstrong , 2013 WL 4853333, at *20-21 (E.D. 10, 2013) (free speech considerations precluded negligent misrepresentation suit over contents of a book); E.S.S. In United States v.

Production 52

Production Trials International Government 52

Drug & Device Law

JUNE 1, 2023

Merrell Dow Pharmaceuticals, Inc. , 2013 WL 7084888, at *2 (Del. 15, 2013), aff’d , 81 A.3d 2013); Collins v. 2013); Jones v. Astrazeneca Pharmaceuticals, LP , 2010 WL 1267219, at *9 (Del. Miles , 414 P.3d 3d 680, 689 (Ariz. Accord Arizona State Hospital/Arizona Community Protection & Treatment Center v.

Testimonials 59

Testimonials Trials Science Government 59

Drug & Device Law

JANUARY 30, 2023

2019), or Mutual Pharmaceutical Co. 472 (2013), implied preemption decisions, cited only by the dissent in Wyeth v. Plaintiffs Legal Committee , 531 U.S. Kent , 552 U.S. 440 (2008) Buckman was not cited at all in the Merck Sharp & Dohme Corp. Albrecht , 139 S. Bartlett , 570 U.S. Levine , 555 U.S. 555 (2009), and rated only a “ cf.

FDA 72

FDA Regulations Production Government 72

Drug & Device Law

OCTOBER 27, 2022

2022), is neither a medical-device nor a pharmaceutical case. 2013); Heisner v. If, by contrast, the agency allowed choice for the convenience of regulated entities rather than to advance its own goals, then the state law escapes preemption under Williamson. The case we discuss today, Vaughan v. Biomat USA, Inc. 3d 1005 (N.D.

FDA 59

FDA Licensing Licensing Regulations 59

Drug & Device Law

JUNE 28, 2022

In enacting the FDCA, Congress created the FDA and charged it with “promot[ing] the public health by promptly and efficiently reviewing clinical research and taking appropriate action on the marketing of regulated products in a timely manner.” 627, 636 (2013). 393(b)(2)(B). Johnson , 568 U.S. 1, 16-22 (2016) (collecting examples).

FDA Approval 116

FDA Approval FDA Drugs Regulations 116

Drug & Device Law

JUNE 2, 2022

This was in contrast to state authority to regulate physicians licensed by the state, as in Planned Parenthood of Cincinnati Region v. 2013), we focused on the court’s endorsement of the “off-label protocol” for RU-486 (mifepristone), which was approved as an abortifacient, as “standard of care.” 472 (2013). (See 2d 891 (W.

FDA Approval 127

FDA Approval Pharmacy FDA Drugs 127