The Premier Consulting Blog

NOVEMBER 12, 2023

In 2019, the FDA published a discussion paper on a proposed regulatory framework for modification to AI/ML-based software as a medical device (SaMD), which received a significant amount of feedback from stakeholders. FDA, 2023 ) As the use of AI/ML in drug development expands, so will the regulatory requirements for these technologies.

FDA 52

FDA Drug Development Regulations FDA Approval 52

New Drug Approvals

OCTOBER 24, 2023

Molecular Weight: 631.700 FDA APPROVED, To treat moderately to severely active ulcerative colitis in adults, 10/12/2023 Velsipity Etrasimod , sold under the brand name Velsipity , is a medication that is used for the treatment of ulcerative colitis (UC). [1] June 2019). 1] It is taken by mouth. [1] 1] It is taken by mouth. [1]

FDA 57

FDA FDA Approval International Pharmacokinetics 57

The Pharma Data

MAY 7, 2021

regulators to seek approval of our COVID-19 vaccine based on our pivotal Phase 3 trial and follow-up data.”. The Pfizer-BioNTech COVID-19 Vaccine has not been approved or licensed by the U.S. “Following the successful delivery of more than 170 million doses to the U.S. CEO and Co-founder of BioNTech. “We

Licensing 52

Licensing Licensing Vaccine FDA Approval 52

Drug Target Review

JULY 5, 2024

Interneuron migration is regulated by L-type calcium channels (LTCCs), encoded by the CACNA1C gene. Recently, a network-based drug-screening platform has been developed to test FDA-approved drugs for Alzheimer’s disease (AD) using 1,300 iPSC-derived organoids from 11 sporadic AD patients. 22:669-679 (2019). Pharmaceutics.

Targeted Protein Degradation 64

Targeted Protein Degradation Drugs FDA Approval Disease 64

The Pharma Data

NOVEMBER 5, 2020

05, 2020 (GLOBE NEWSWIRE) — Collegium Pharmaceutical, Inc. Nasdaq: COLL), a specialty pharmaceutical company committed to being the leader in responsible pain management, today reported its financial results for the quarter ended September 30, 2020 and provided a corporate update. FDA approval, and customary exceptions).

Pharmaceuticals 52

Pharmaceuticals Production Marketing Pharmaceutical Companies 52

Drug Discovery World

APRIL 14, 2023

as a master regulator of prostate differentiation and cancer initiation and progression, for generating unique and reliable murine bladder and prostate cancer models, and for steadfast commitment to serving as a leader, mentor, and supporter of women in cancer research. Wherry’s award lecture will be held on Monday April 17 at 3:30pm ET.

Clinical Trials 130

Clinical Trials Research Science Clinical Research 130

The Pharma Data

SEPTEMBER 9, 2020

ENSPRYNG is the first and only FDA-approved subcutaneous, self-administered medicine for NMOSD and the first medicine for NMOSD that is designed to target the interleukin-6 receptor, which is believed to play a key role in the inflammation associated with this disorder.”. ENSPRYNG is approved in Canada, Japan, Switzerland and the U.S.

Treatment 52

Treatment Disease Therapies FDA 52

The Pharma Data

APRIL 27, 2021

Takeda Pharmaceutical Company Limited ( TSE:4502/NYSE:TAK ) (“Takeda”) today announced that that the U.S. In 2019, the U.S. FDA granted mobocertinib Orphan Drug Designation for the treatment of lung cancer with HER2 mutations or EGFR mutations including Exon20 insertion mutations. About Takeda Pharmaceutical Company Limited.

FDA 52

FDA Treatment Pharmaceutical Companies FDA Approval 52

The Pharma Data

JANUARY 24, 2021

Management of the Company believe that the proposed acquisition will strengthen PharmaDrug’s product pipeline, intellectual property portfolio and pharmaceutical development expertise. Sairiyo recently received FDA orphan drug designation for Cepharanthine in the treatment of esophageal cancer. About PharmaDrug Inc.

FDA 52

FDA Drugs Clinical Development Pharmaceutical Companies 52

The Pharma Data

FEBRUARY 8, 2021

Food and Drug Administration (FDA) approval for nmCRPC on February 14, 2018 and was approved for mCSPC on September 17, 2019. About the Janssen Pharmaceutical Companies of Johnson & Johnson. ERLEADA ® received U.S. 2 To date, more than 10,000 patients worldwide have been treated with ERLEADA ®.

Treatment 52

Treatment Pharmaceutical Companies Therapies Pharmaceuticals 52

The Pharma Data

JANUARY 9, 2021

. Revenue Metrics Total revenues for 2020 are expected to be in the range of $1,545 and $1,555 million, an increase at the midpoint of $444 million or 40% as compared to 2019. 2019 (Actual). 2019 (Actual). 2019 (Actual). FOOTNOTES.

Government 52

Government Vaccine Production Licensing 52

Agency IQ

JANUARY 12, 2024

After lengthy review, FDA approves Florida’s drug importation plan After a years-long review process, the FDA today announced its approval of Florida’s proposal to import certain prescription drug products from Canada.

FDA Approval 40

FDA Approval FDA Science Drugs 40

Agency IQ

JUNE 16, 2023

The 51 regulations that FDA is currently working on The FDA today unveiled its much-anticipated Spring 2023 Unified Agenda, a document outlining the regulations the agency plans to release in 2023 and beyond. The anticipated date of publication is June 2023, meaning we should see this regulation imminently.

Regulations 40

Regulations FDA Science Production 40

The Pharma Data

NOVEMBER 4, 2020

Total Revenue Increased 39% in Third Quarter 2020 and 56% in First Nine Months of 2020 Compared toSame Periods of 2019 Despite COVID-19 Headwinds. Progress Continues Towards VASCEPA® (icosapent ethyl) Approval and Commercialization in Europe. million, an increase of 56% compared to the same period in 2019.

Production 40

Production FDA Trials Licensing 40

The Pharma Data

JANUARY 21, 2021

21, 2021 /PRNewswire/ — The Janssen Pharmaceutical Companies of Johnson & Johnson today announced the U.S. Results from these trials were presented at the 2019 Conference on Retroviruses and Opportunistic Infections (CROI). TITUSVILLE, N.J. , Global Head, Janssen Research & Development, Johnson & Johnson. cp-51575v4.

FDA Approval 52

FDA Approval Treatment RNA FDA 52

The Pharma Data

AUGUST 6, 2020

Otezla® Divestiture) occurred on January 1, 2019 and exclude foreign currency hedge gains and losses. All comparisons are made versus the same period in 2019 unless otherwise stated. The increase was driven primarily by the impact of the Celgene Acquisition, which was completed on November 20, 2019. Second Quarter. . .

Production 52

Production International Licensing Licensing 52

The Pharma Data

JANUARY 13, 2021

“Receiving Fast Track designation is an important acknowledgment of the results of our COVID-19 laboratory research,” commented Leo Ehrlich, Chief Executive Officer at Innovation Pharmaceuticals. Alerts Sign-up for Innovation Pharmaceuticals email alerts is available at: [link]. Source link.

Clinical Trials 52

Clinical Trials Trials Pharmaceuticals FDA 52

The Pharma Data

NOVEMBER 9, 2021

Johnson & Johnson and its Janssen Pharmaceutical Companies moment blazoned they will appeal the$ 572 million civil judgment entered in Cleveland County District Court in the State of Oklahoma’s action against opioid manufacturers. The FDA-approved markers of these drugs give clear information about their pitfalls and benefits.

Pharmaceutical Companies 52

Pharmaceutical Companies FDA Approval Pharmaceuticals FDA 52

The Pharma Data

OCTOBER 29, 2020

29, 2020– Alexion Pharmaceuticals, Inc. million , a 26 percent increase compared to the same period in 2019. Non-GAAP diluted EPS for the third quarter of 2020 was $3.24 , a 16 percent increase versus the third quarter of 2019. million in the third quarter of 2019. million in the third quarter of 2019.

Clinical Trials 40

Clinical Trials Production Trials Licensing 40

Agency IQ

SEPTEMBER 29, 2023

What We Expect the FDA to do in October 2023 In this ongoing feature, AgencyIQ looks at public data to determine what the FDA is likely to do in the month ahead, including key deadlines, meetings, events, planned regulations, comment periods and more.

FDA 40

FDA Science Regulations Production 40

The Pharma Data

JANUARY 5, 2021

based contract manufacturing business, Benuvia Manufacturing, which has significant chemistry and formulation capabilities, including manufacturing our FDA-approved cannabinoid drug, SYNDROS ® ,” said Todd C. Within PWS, cannabidiol targets signaling pathways and receptors that regulate the physical symptoms of hyperphagia and anxiety.

Disease 52

Disease FDA Approval Clinical Trials FDA 52

Agency IQ

DECEMBER 1, 2023

What We Expect the FDA to do in December 2023 In this ongoing feature, AgencyIQ looks at public data to determine what the FDA is likely to do in the month ahead, including key deadlines, meetings, events, planned regulations, comment periods and more.

FDA 40

FDA Science Regulations Production 40

Agency IQ

OCTOBER 27, 2023

What We Expect the FDA to do in November 2023 In this ongoing feature, AgencyIQ looks at public data to determine what the FDA is likely to do in the month ahead, including key deadlines, meetings, events, planned regulations, comment periods and more.

FDA 40

FDA Science Regulations Production 40

The Pharma Data

SEPTEMBER 2, 2020

New Phase III data from SAkuraStar and SAkuraSky studies demonstrate reduced severity of relapses with ENSPRYNG (satralizumab), recently FDA-approved as the first and only subcutaneous treatment for adults living with anti-aquaporin-4 (AQP4) antibody positive neuromyelitis optica spectrum disorder (NMOSD).

Clinical Trials 52

Clinical Trials Disease Treatment Therapies 52

Agency IQ

JANUARY 26, 2024

The cost of artificially short expiration dates: Worsened shortages, higher costs and more waste As drug shortages have made headlines over the past few years, the FDA has announced the extension of expiration dates on a variety of drug products. The results of this survey were provided in a report to the AMA’s Council on Scientific Affairs.

Science 40

Science FDA Packaging Production 40

The Pharma Data

DECEMBER 8, 2020

OSAKA, Japan–( BUSINESS WIRE )– As part of its Wave 1 Pipeline Market Opportunity Call, Takeda Pharmaceutical Company Limited ( TSE:4502/NYSE:TAK ) (“Takeda”) provided an update on its pipeline portfolio, which has the potential to contribute significantly to revenue growth for the company over the next decade. 9, 2020 00:15 UTC.

Pharmaceutical Companies 52

Pharmaceutical Companies FDA Approval Therapies Vaccine 52

The Pharma Data

FEBRUARY 8, 2021

Food and Drug Administration (FDA) approval for nmCRPC on February 14, 2018 and was approved for mCSPC on September 17, 2019. About the Janssen Pharmaceutical Companies of Johnson & Johnson. 2 ERLEADA ® received U.S. To date, more than 10,000 patients worldwide have been treated with ERLEADA ®.

Pharmaceutical Companies 52

Pharmaceutical Companies Treatment Clinical Trials Trials 52

Codon

MARCH 24, 2024

A 2019 report from RethinkX, an independent research group, states that the “cost to produce a single molecule using [precision fermentation] has fallen from $1 million per kilogram in 2000, to about $100 today.” In response to this hysteria, regulation was aggressively tightened.

Engineering 85

Engineering Vaccine Production RNA 85

Codon

JUNE 18, 2024

For more than a century, scientists thought of gas vesicles as little more than a natural curiosity and, later, as a way for microbes to regulate buoyancy. In 2019, a Ph.D. At least six types of CAR-T cells have already passed through clinical trials and garnered FDA approval.

Engineering 66

Engineering Laboratories International Clinical Trials 66

The Pharma Data

OCTOBER 28, 2020

OSAKA, Japan–( BUSINESS WIRE )– Takeda Pharmaceutical Company Limited ( TSE:4502/NYSE:TAK ) (“Takeda”) today announced financial results for the first half of fiscal year 2020 (period ended September 30, 2020). billion cash received for Xiidra® in July 2019. 29, 2020 06:19 UTC. Further de-leveraging in H1 led to a 3.7x

Pharmaceutical Companies 40

Pharmaceutical Companies Engineering Therapies Clinical Trials 40

The Pharma Data

MAY 4, 2021

up 28%, primarily driven by continued strong demand in the metastatic and non-metastatic castration-resistant prostate cancer indications, as well as the metastatic castration-sensitive prostate cancer indication, which was approved in the U.S. in December 2019; and. 7) BNT162b2 has not been approved or licensed by the U.S.

Vaccine 40

Vaccine Production FDA Clinical Trials 40

The Pharma Data

JANUARY 29, 2021

January 29, 2021 – Johnson & Johnson (NYSE: JNJ) (the Company) today announced topline efficacy and safety data from the Phase 3 ENSEMBLE clinical trial, demonstrating that the investigational single-dose COVID-19 vaccine in development at its Janssen Pharmaceutical Companies met all primary and key secondary endpoints.

Vaccine 40

Vaccine Trials Pharmaceutical Companies Immune Response 40

Drug & Device Law

DECEMBER 21, 2023

FDA , 78 F.4th 2023), was the Fifth Circuit’s blatantly politicized attack on the FDA’s regulation of abortion-related drugs. That’s significant because the labels for over 500 drugs already have such information, under a voluntary FDA program. Takeda Pharmaceutical Co. , 4th 210 (5th Cir.

FDA Approval 52

FDA Approval FDA Drugs Production 52

Drug & Device Law

MARCH 25, 2022

2019), was decided, we included it as both our best decision of 2019 , and as our sixth worst case. Even before the anti-osteoporosis drug Fosamax was FDA approved, its manufacturer was aware of a biologically plausible mechanism for that class of drug (“bisphosphonates”) to cause low-energy – later renamed “atypical” ?

FDA 52

FDA Regulations Science Drugs 52

Drug & Device Law

JANUARY 9, 2023

Then, the decision makes a hash of the relevant administrative record, ignoring what the preemptive FDA regulations said in favor of material from the Federal Register that never actually made it into the regulations themselves. Bayer Healthcare Pharmaceuticals Inc. 2019), and Levine. 379r(e). Albrecht , 139 S.

Regulations 59

Regulations Nurses FDA FDA Approval 59

Drug & Device Law

JUNE 2, 2022

2012), addressed a challenge to the application of Idaho’s Pain-Capable Unborn Child Protection Act to criminalize the use of an FDA-approved abortifacient medication obtained through an internet prescription and mailed to the plaintiff from out of state. As we discussed here , McCormack v. Hiedeman, 694 F.3d 3d 1004 (9th Cir.

FDA Approval 127

FDA Approval Pharmacy FDA Drugs 127

Drug & Device Law

JANUARY 30, 2023

2019), or Mutual Pharmaceutical Co. 280 (1995), decision that he joined in 1995 He joined a decision that found no preemption by virtue of a governmental decision not to regulate in Myrick and did not object to boilerplate description of obstacle preemption as an accepted preemption category Then in the 5-4 Geier v.

FDA 72

FDA Regulations Production Government 72