Camargo

NOVEMBER 11, 2020

Unpacking the (Black) Box: Antares Licenses Urology Product with Boxed Warning. When the FDA requires a product’s labeling to include a boxed warning (also called a “black box warning” because the text is surrounded by black border), the potential market value of the drug often drops severely. In October, the U.S.

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The Pharma Data

DECEMBER 15, 2020

Under the agreement, Aurena Laboratories will establish a production unit to meet the regulatory requirements for the manufacture of Lipidor’s pharmaceutical products. This will enable Lipidor to offer potential licensees the opportunity for large-scale commercial production.

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XTalks

DECEMBER 8, 2023

March-in rights is a measure to help agencies evaluate when it might be appropriate to relinquish patent licenses when products developed with federal funding aren’t readily accessible to the public. The guidance is the product of an interagency review that began early this year.

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The Pharma Data

MAY 7, 2021

population in just a few months, the BLA submission is an important cornerstone of achieving long-term herd immunity and containing COVID-19 in the future,” said Ugur Sahin, M.D., regulators to seek approval of our COVID-19 vaccine based on our pivotal Phase 3 trial and follow-up data.”. CEO and Co-founder of BioNTech. “We

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Advarra

APRIL 30, 2024

Investigator Site Files The ISF contains essential documents permitting evaluation of a clinical trial’s conduct. A cross-check ensures curriculum vitae (CVs), and medical licenses (if appropriate) are on file and current. In some countries, local regulations may indicate the sub-investigators need to sign as well.

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World of DTC Marketing

MAY 24, 2022

DEA agents interviewed former Cerebral employees about clinician licensing issues and allegations that some patients had set up multiple accounts to obtain more drugs, Insider reported , citing sources. Many claims may or may not accurately reflect what these products offer, “It’s the wild west.”. Does this mean we should give up?

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The Pharma Data

DECEMBER 13, 2020

. Relay Therapeutics will receive $75 million upfront and is eligible to receive an additional $25 million in near-term payments and $695 million in additional potential milestones, plus royalties on global net product sales. Relay Therapeutics to host conference call at 8:00 a.m. CAMBRIDGE, Mass., About RLY-1971.

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XTalks

APRIL 24, 2023

Dr. Eagleton recently spoke on a webinar with his colleagues from Medpace about lessons learned from successful approaches from rare disease and gene therapy product approvals. Last year, the FDA approved five novel cellular and gene therapy products with orphan drug designation.

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The Pharma Data

MAY 14, 2021

Product Name: Weight Dissolver – Video Presentation. If within the first 60 days of receipt you are not satisfied with Wake Up Lean , you can request a refund by sending an email to the address given inside the product and we will immediately refund your entire purchase price, with no questions asked. Start Now |. Terms of Use |.

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pharmaphorum

MARCH 26, 2021

Surprisingly, although the TCA is voluminous at 1250 pages, it is not comprehensive for most regulated industries. Medicinal products are mentioned only in passing. This applies equally to medicinal products and medical devices as to any other type of goods. The Medicinal Products Annex.

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FDA Law Blog

MARCH 13, 2024

156 for certain FDA-regulated products, we know what you were thinking. Part 2 (“Part Deux”) investigated the PTO’s position and recent decisions on PTE applications for patents covering products approved—and then withdrawn years later—under the Federal Food, Drug, and Cosmetic Act’s Accelerated Approval provisions (and otherwise).

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Druggist

FEBRUARY 28, 2021

In other words, melatonin acts as a biological clock that regulates sleep. Melatonin, therefore, can be used to promote and regulate sleep (Wagner et al., In the UK, licensed forms of melatonin are prescribed either for the management of insomnia in adults over 55 years of age or to help with jet lag. Can buy melatonin abroad?

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Drug Discovery World

AUGUST 3, 2023

Medical cannabis is often a first-thought when regarding plant-based medicines, but there remains public scepticism, arguably due to the regulations relating to the substance. There is, however, one cannabis-derived drug product that the FDA has approved, which is Epidiolex (cannabidiol).

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The Pharma Data

JANUARY 18, 2021

In yesterday’s online edition of Forbes magazine, Ahmad Doroudian, CEO of BetterLife, further emphasized the significant barriers that current regulations impose on development of the current generation of psychedelics and LSD based compounds and advantages of non-controlled second generation psychedelics such as TD-0148A.

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Pfizer

APRIL 26, 2023

Our engineers created specially designed, temperature-controlled shipping containers (that we call “shippers”), which contain GPS temperature enabled trackers for continuous, real-time location and temperature monitoring and can maintain required temperature conditions for up to 10 days unopened.

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Drug Discovery World

FEBRUARY 1, 2023

But for this market to become a reality, we need much more research into cannabis products and potential indications. Growing the cannabis and manufacturing the products, for example, often must be conducted in completely different countries due to the varying levels of legislation in each European country.

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Clinical Trials Clinical Trials Medicine Trials 52

The Pharma Data

DECEMBER 23, 2020

The Company advises that it is not making any express or implied claims that Ifenprodil has the ability to eliminate, cure or contain COVID-19 (or the SARS-2 Coronavirus) at this time. Forward-looking statements contained in this news release are expressly qualified by this cautionary statement. About NP-120 (Ifenprodil).

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Containment Regulation Compliance Development 52

FDA Law Blog

FEBRUARY 29, 2024

156, as added by the 1984 Hatch-Waxman Amendments, for certain FDA-regulated products. The PTO’s ORDER TO SHOW CAUSE points out that: According to the published Federal Register Notice of July 17, 2020, Lilly requested withdrawal “(revocation)” of its BLA for the human biological product LARTRUVO® (olaratumab).

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The Pharma Data

OCTOBER 15, 2020

Researchers at MSK developed naxitamab and omburtamab, which are exclusively licensed by MSK to Y-mAbs. As a result of this licensing arrangement, MSK has institutional financial interests related to the compounds and Y-mAbs. About Y-mAbs. Forward-Looking Statements.

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The Pharma Data

JANUARY 10, 2021

Based on its leading expertise in antibody, protein and peptide technologies, MorphoSys, together with its partners, has developed and contributed to the development of more than 100 product candidates, of which 27 are currently in clinical development. In July 2020, the U.S. subsidiary MorphoSys US Inc., has more than 600 employees.

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The Pharma Data

DECEMBER 28, 2020

This news release contains forward-looking statements relating to product development, licensing, commercialization and regulatory compliance issues and other statements that are not historical facts. Forward-looking statements contained in this news release are expressly qualified by this cautionary statement.

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Pfizer

DECEMBER 13, 2022

One carton contains five blister packs of PAXLOVID, as co-packaged nirmatrelvir tablets with ritonavir tablets, providing all required doses for a full five-day treatment course. The state-licensed pharmacist should refer an individual patient for clinical evaluation (e.g., Herbal Products: St. AUTHORIZED USE .

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Pfizer

JANUARY 27, 2023

One carton contains five blister packs of PAXLOVID, as co-packaged nirmatrelvir tablets with ritonavir tablets, providing all required doses for a full five-day treatment course. The dose for patients with moderate renal impairment (eGFR ≥30 to For more information, please visit www.PAXLOVID.com. AUTHORIZED USE The U.S.

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The Pharma Data

JANUARY 26, 2021

Food and Drug Administration’s Office of Orphan Products Development has granted Orphan Drug Designation to Uttroside-B , a small molecule chemotherapeutic for the treatment of hepatocellular carcinoma (HCC), the most common form of liver cancer. . NEW YORK , Jan. 27, 2021 /PRNewswire/ — Q Biomed Inc.

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The Pharma Data

DECEMBER 20, 2020

It is our continual objective to broaden our product scope, and Transcend, with its experienced management team, is a perfect foothold for us in the fast-growing market for psychedelics molecules and complements our existing pipeline of treatments. per share, with the transaction valued at $10 million. “We

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Drug Delivery Containment Production Development 52

The Pharma Data

MARCH 14, 2021

This is much lower than would be expected to occur naturally in a general population of this size and is similar across other licensed COVID-19 vaccines. During the production of the vaccine more than 60 quality tests are conducted by AstraZeneca, its partners and by more than 20 independent testing laboratories.

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The Pharma Data

JULY 27, 2021

Amgen Forward-Looking Statements This news release contains forward-looking statements that are based on the current expectations and beliefs of Amgen. Further, preclinical results do not guarantee safe and effective performance of product candidates in humans.

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Production Antibody Sales Manufacturing 52

The Pharma Data

NOVEMBER 27, 2020

(the “Company” or “Y-mAbs”) (Nasdaq: YMAB) a commercial-stage biopharmaceutical company focused on the development and commercialization of novel, antibody-based therapeutic products for the treatment of cancer, today announced that the U.S. The FDA granted approval under the accelerated approval regulation.

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The Pharma Data

JANUARY 12, 2021

With the phase of the Agreement relating to the development of the antibody completed, under the Agreement, as of 11 January 2021, GlobalCo has three months to exercise an option to license the Company’s intellectual property necessary to exploit the CDX antibody on an exclusive worldwide basis (“Option”). .

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Pfizer

JANUARY 27, 2023

In a limited number of cases when a full virus does not contain any known gain of function mutations, such virus may be engineered to enable the assessment of antiviral activity in cells. and global regulators for all antiviral products and are carried out by many companies and academic institutions in the U.S.

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Advarra

JULY 19, 2022

The standard for the audit used depends on the type of vendor and would include the applicable regulations and ICH guidelines. Do you search for similar products, and use existing IND criteria requirements against the latest manufacturing guidance docs? At what point does the drug substance become a drug product?

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Pfizer

DECEMBER 20, 2022

One carton contains five blister packs of PAXLOVID, as co-packaged nirmatrelvir tablets with ritonavir tablets, providing all required doses for a full five-day treatment course. The state-licensed pharmacist should refer an individual patient for clinical evaluation (e.g., Herbal Products: St. AUTHORIZED USE.

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Pharma in Brief

JANUARY 10, 2021

s ( Allergan ) silodosin capsules (marketed as RAPAFLO ® ) under an exclusive license in Canada granted by Kissei Pharmaceutical Co., The Court’s decision concerns Canadian Patent No. 2,507,002 ( 002 Patent ), which is listed on the patent register against Allergan Inc.’s Allergan brought an action against Sandoz Canada Inc.

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Drug Discovery World

MARCH 29, 2023

However, stakeholders should be aware that the leaked review contains no such analysis. They ask: “Which proportion of products in the data sets would have qualified for the newly defined UMN or ‘High UMN’ status, and be eligible for the corresponding ‘smaller losses’ of regulatory incentives?

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Clinical Trials Clinical Trials Production Medicine 52

The Pharma Data

OCTOBER 27, 2020

The product listing offered on Amazon.ca Now with the distribution by Amazon there will be greater access for Canadians as well as quicker delivery times, especially for an important product like DermSafe that will help people fight the battle against this pandemic,” said Mr. Terry Howlett, President of Ovation. shops/dermsafe.

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The Pharma Data

JANUARY 12, 2021

where he managed and oversaw a large portion of the Regeneron pipeline portfolio including leading the immunology and inflammation antibody products across all stages of development from preclinical to post-launch. THIS ANNOUNCEMENT CONTAINS INSIDE INFORMATION FOR THE PURPOSES OF ARTICLE 7 OF REGULATION (EU) NO 596/2014.

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The Pharma Data

JANUARY 10, 2021

. VALBIOTIS has adopted an innovative approach, aiming to revolutionize healthcare by developing a new class of health nutrition products designed to reduce the risk of major metabolic diseases, based on a multi-target approach enabled by the use of plant-based ingredients.

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