The Pharma Data

APRIL 26, 2022

These data were presented at the 29th Conference on Retroviruses and Opportunistic Infections (virtual CROI 2022). Veklury was approved by the FDA in October 2020, for adults and pediatric patients 12 years of age and older and weighing at least 40 kg for the treatment of COVID-19 requiring hospitalization. Gilead Sciences, Inc.

Treatment 52

Treatment Hospitals Science Licensing 52

Agency IQ

OCTOBER 6, 2023

All products are received in one of two forms: A New Drug Application (or NDA, for pharmaceuticals) or a Biologics License Application (BLA, for biologics). Novel drug products are defined as products that have never been approved for any indication. FDA approved 13 NMEs through the AA pathway in FY 2023, making up 25.5%

FDA 52

FDA Biosimilars Science Production 52

FDA Law Blog: Biosimilars

FEBRUARY 29, 2024

The use of a surrogate endpoint can considerably shorten the time required prior to receiving FDA approval. If the confirmatory trial shows that the drug actually provides a clinical benefit, then the FDA grants traditional approval for the drug. FDA-2022-E-3124 ). 6,992,207 covering PEPAXTO (Docket No.

FDA 57

FDA Production FDA Approval Compliance 57

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] July 2022). 1] It is taken by mouth. [1] 401 (10383): 1159–1171.

FDA 57

FDA FDA Approval International Pharmacokinetics 57

Agency IQ

JANUARY 19, 2024

For example, in 2023, the EMA published its 2022 highlights report on February 16, followed by the detailed report on May 15. This most recent year saw 80 total opinions, compared to 92 in 2022 and 97 in 2021. The EMA has now seen a three-year decline in new active substances, with 54 in 2021, 44 in 2022 and 39 in 2023.

Biosimilars 40

Biosimilars FDA Production Treatment 40

The Pharma Data

MARCH 27, 2022

In February 2022, the U.S. Food and Drug Administration (FDA) granted priority review for OLUMIANT in severe AA as a potential first-in-disease medicine. European Union and Japan in 2022. “In 2022, OLUMIANT could become the first medicine ever approved to treat adults with alopecia areata.

Licensing 40

Licensing Licensing Disease FDA Approval 40

The Pharma Data

JUNE 7, 2022

. “We look forward to providing an important new medicine and helping patients find the relief they so desperately seek from the varied and debilitating symptoms of this disease, contingent upon FDA approval.” With these data, Lilly plans to submit a Biologics License Application (BLA) to the U.S. Almirall S.A.’s

Trials 40

Trials Clinical Trials Licensing Licensing 40

The Pharma Data

MAY 31, 2022

Food and Drug Administration (FDA) has accepted for priority review the supplemental Biologics License Application (sBLA) for Dupixent® (dupilumab) to treat adults with prurigo nodularis, a chronic inflammatory skin disease that causes extreme itch and skin lesions. The target action date for the FDA decision is September 30, 2022.

FDA 52

FDA Disease Trials FDA Approval 52

The Pharma Data

APRIL 4, 2022

If approved, Dupixent would be the first medicine available in the U.S. The target action date for the FDA decision on this investigational use is August 3, 2022. Regulatory filings around the world are also planned in 2022. indicated to treat eosinophilic esophagitis There are approximately 160,000 patients in the U.S.

FDA 52

FDA Treatment Disease FDA Approval 52

Agency IQ

APRIL 26, 2024

Can information about a biosimilar product be included in promotional materials, even if it isn’t specifically included in the product’s actual FDA-approved labeling? Information regarding interchangeability would remain available only in the Purple Book: Database of Licensed Biological Products. Yes, the guidance confirms.

Biosimilars 40

Biosimilars Science FDA Licensing 40

New Drug Approvals

DECEMBER 16, 2023

August 2022). 1 Factor B is a positive regulator of the alternative complement pathway, where it activates C3 convertase and subsequently C5 convertase. 2 This is of particular importance to PNH, where one of the disease hallmarks is the mutation of the PIGA gene. . 5 December 2023. . twitter +919321316780 call whatsaapp EMAIL.

FDA 62

FDA Small Molecule FDA Approval Treatment 62

The Pharma Data

MAY 2, 2022

Under the terms of the settlement agreement, the litigation between the parties in the United States District Court for the District of New Jersey will be ended, and Lupin will have a license to sell its generic product beginning April 2033, or earlier under certain circumstances. On March 9, 2022, the U.S.

Production 52

Production Pharmaceuticals Treatment Disease 52

Codon

JULY 14, 2024

In January 2022, the American Red Cross declared its first-ever national blood crisis owing to a severe blood shortage—the worst shortfall in more than a decade. Despite the high costs, researchers in Kyoto generated enough cultured platelets in 2022 to transfuse a 55-year-old woman for an initial human trial.

Production 131

Production Clinical Trials Trials Therapies 131

Codon

APRIL 2, 2023

Comparing the economic terms of biotechnology licenses from academic institutions with those between commercial firms. Read Economic terms were compared for 239 biotechnology licenses issued to academic institutions and 916 similar licenses at commercial firms. from 2021 to 2022, up to $625 million. Will Bedingfield.

DNA 52

DNA RNA Engineering Licensing 52

The Pharma Data

FEBRUARY 13, 2022

If approved, Dupixent will be the first biologic medicine available in the U.S. The target action date for the FDA decision on this investigational use is June 9, 2022. Dupixent remains the only biologic medicine approved for patients 6 years of age and older in this indication.

FDA 40

FDA Disease Treatment FDA Approval 40

Agency IQ

JUNE 2, 2023

The FDA recently concluded its work on a proposed rule focused on PMI. The regulator sent the rule to the White House’s Office of Information and Regulatory Affairs (OIRA) on October 4, 2022. OIRA eventually released the rule for release by the FDA (with changes) on May 10, 2023.

FDA 40

FDA FDA Approval Production Regulations 40

The Pharma Data

JANUARY 13, 2021

Germany-based Cevec Pharmaceuticals GmbH signed a licensing agreement with Biogen for the use of its proprietary ELEVECTA Technology for the manufacturing of adeno-associated virus (AAV) vectors for gene therapy applications. Vivity received FDA approval in February 2020. Top-line results are expected in the first half of 2022.

Licensing 52

Licensing Licensing Clinical Trials Trials 52

Agency IQ

JUNE 16, 2023

FDA’s is generally consistent from edition to edition , will each edition consisting primarily of holdovers from previous editions. The latest Fall 2022 Unified Agenda contains 51 regulations that FDA plans to publish related to human medical product regulation. Read our analysis of that rule here and here. ]

Regulations 40

Regulations FDA Science Production 40

Agency IQ

NOVEMBER 3, 2023

Although this guidance document is mostly focused on chemistry, manufacturing and control (CMC) information, it clarifies that LBPs are considered biologics, and will thus need to utilize the Biologics License Application (BLA) pathway. These reasons tend to become self-evident when the other regulatory classifications are understood.

Therapies 40

Therapies Science FDA Production 40

Agency IQ

JANUARY 26, 2024

Such a situation is commonplace in the clinical trial realm, in which investigational drug products which are not already FDA approved are administered to patients. Under the Pandemic and All-Hazards Preparedness Reauthorization Act of 2013 (PAHPRA) , the FDA also has some authority to extend MCM expiration dates.

Science 40

Science FDA Production Packaging 40

The Pharma Data

AUGUST 3, 2021

Food and Drug Administration (FDA) approved LUMAKRAS for the treatment of adult patients with KRAS G12C-mutated locally advanced or metastatic NSCLC, as determined by an FDA-approved test, who have received at least one prior systemic therapy. In May, the U.S. Tezepelumab. Rozibafusp alfa (AMG 570). Olpasiran (AMG 890).

Biosimilars 52

Biosimilars Production Treatment FDA 52

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. The following PDUFA dates were obtained from publicly available sources.

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. November is packed with regulatory and industry meetings.

FDA 40

FDA Science Regulations Production 40

FDA Law Blog: Biosimilars

MARCH 13, 2024

4,631,286, where the PTO considered “whether Hoechst-Roussel is eligible to file an application for [PTE] based on a regulatory review conducted by its competitor, the marketing applicant Warner-Lambert, wherein Hoechst-Roussel was not associated with the regulatory review that led to FDA approval for commercial marketing of the approved product.”

FDA 57

FDA FDA Approval Production Marketing 57

FDA Law Blog: Biosimilars

MAY 21, 2024

Even though President Joe Biden had asked the Secretary of HHS and the Attorney General to “initiate the administrative process to review expeditiously how marijuana is scheduled under federal law” in October 2022 , we also wondered how the Department of Justice (“DOJ”) and DEA would receive the HHS recommendation. Basis at 63-64.

Regulations 67

Regulations FDA Treatment Drugs 67

FDA Law Blog: Biosimilars

SEPTEMBER 5, 2023

Cannabis in schedule III would require a prescription issued by a DEA-registered, state-licensed practitioner. FDA had not approved an NDA or ANDA for cannabis for any indication in 2016. FDA did approve Epidiolex , a cannabidiol oral solution derived from cannabis, in June 2018.

FDA 109

FDA Treatment Drugs FDA Approval 109

The Pharma Data

MAY 4, 2021

Food and Drug Administration (FDA) approved the supplemental New Drug Application (sNDA) for Lorbrena, expanding the indication to include first-line treatment of people with anaplastic lymphoma kinase (ALK)-positive non-small cell lung cancer (NSCLC). If approved, TicoVac would be the first vaccine in the U.S.

Vaccine 40

Vaccine Production FDA Clinical Trials 40

The Pharma Data

APRIL 26, 2021

billion declined, mainly due to the USD 650 million upfront payment to in-license tislelizumab from BeiGene. Key innovation milestones: Entresto granted an expanded indication by the FDA in chronic heart failure patients (to include HFpEF). New approvals. Free cash flow¹ of USD 1.6 Financials. First quarter. Exjade/Jadenu.

Production 40

Production Licensing Licensing Clinical Trials 40

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. The December calendar is packed with regulatory and industry meetings.

FDA 40

FDA Science Regulations Production 40

New Drug Approvals

JULY 10, 2023

If FDA approved, it will join other previously-approved “-gepant” drugs [ rimegepant ] and [ ubrogepant ] as an additional treatment alternative for patients with migraine, particularly those for whom traditional triptan therapy has proven ineffective. doi : 10.2217/pmt-2022-0054. . 10 March 2023.

Clinical Trials 40

Clinical Trials Treatment FDA Trials 40

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. Read our analysis of the lawsuit against the drug importation rule here. ]

FDA Approval 40

FDA Approval FDA Science Drugs 40

Policy Prescription

OCTOBER 3, 2023

That’s why, according to Salant, drug companies “[blur] the distinction between dangerous counterfeit drugs and safe drugs sold by pharmacies licensed in other high-income countries.” In the summer of 2022, a policy debate in the Senate HELP committee ensued with Sens. but negotiate higher prices in foreign markets.

Pharmacy 84

Pharmacy International FDA Approval Government 84

FDA Law Blog: Biosimilars

MAY 5, 2024

Background In October 2022, President Biden directed the Health and Human Services (“HHS”) Secretary and the Attorney General to “initiate the administrative process to review expeditiously how marijuana is scheduled under federal law.” After the public comment period closes, DEA will review comments and issue a final rule.

FDA 94

FDA Regulations Treatment Licensing 94

FDA Law Blog: Biosimilars

FEBRUARY 11, 2024

Few would oppose FDA-approved marijuana-derived medications if marijuana compounds are found to have medical value; the National Institute of Health should continue to fund research on any potential medical value of marijuana and on the harms of highly potent products. July 6, 2022). Letter to President Joseph Biden, et al.

Regulations 57

Regulations Production FDA Approval Drugs 57

Drug & Device Law

SEPTEMBER 7, 2023

For instance, Sorsaia primarily involves a challenge to a state trying to prevent in-state use of an FDA-approved drug for its FDA-approved use. 2587 (2022), essentially wiped out the possibility of preemption. Last week, the district court in GenBioPro, Inc. EPA , 142 S. emphasis in original). or attempt[] to.

FDA Approval 59

FDA Approval FDA Licensing Licensing 59

Drug & Device Law

DECEMBER 29, 2023

As a matter of science, the purported link was imaginary, as discussed at great length in one of the many excellent Zantac ( 2022+4 ) MDL opinions. Legally the State of California – or, more accurately, a private litigant purporting to exercise state powers – has no such power, because warnings on OTC drugs must be approved by the FDA.

Testimonials 105

Testimonials FDA Drugs Vaccine 105

Drug & Device Law

FEBRUARY 2, 2023

2022 WL 17443711, at *2 (5th Cir. 6, 2022) (applying Texas law), applying this standard in a Texas medical device decision. Texas has a rebuttable presumption that FDA-approved prescription drug labels are adequate, and Plaintiff here is unable to rebut that presumption. See Harrison v. Medtronic, Inc. manufacturer, . .

Production 59

Production FDA Approval Vaccine FDA 59