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 is an important step towards a licensing agreement for Lipidor drug candidates, AKP01 and AKP02, for the treatment of psoriasis.

Contract Manufacturing 52

Contract Manufacturing Manufacturing Production Drugs 52

Druggist

MAY 12, 2021

Celevac is a brand of tablets containing methylcellulose. Each Celevac tablet contained 500mg of methylcellulose. Celevac tablets were licensed as general sale list medicines (GSL), which means they could be sold in any retail outlet, including pharmacies, over the counter without a prescription. . To help with diarrhoea.

Containment 97

Containment Production Pharmacy Licensing 97

The Pharma Data

OCTOBER 19, 2020

manufacturer, Pharmaceutics International, Inc. (“Pii”), has completed the manufacturing process for Berubicin Drug Product, its lead drug candidate for the treatment of glioblastoma multiforme (GBM), an aggressive form of brain cancer currently considered incurable. . .

Clinical Trials 52

Clinical Trials Clinical Trials Manufacturing Trials 52

The Pharma Data

DECEMBER 13, 2020

The FDA also recommended that Gamida Cell generate additional manufacturing-related data prior to requesting a pre-Biologics License Application (BLA) meeting. Specifically, the FDA requested that Gamida Cell demonstrate analytical and clinical comparability from the company’s planned commercial manufacturing sites.

Licensing 52

Licensing Licensing Clinical Trials Clinical Trials 52

Druggist

DECEMBER 28, 2020

Fexofenadine over the counter will be available as a branded product – Allevia 120mg tablets (each tablet contain 120mg of fexofenadine hydrochloride). Allevia tablets will be licensed as General Sale Item (GSL), which means it will be available over the counter in shops and supermarkets and not only in pharmacies.

Pharmacy 98

Pharmacy Doctors Doctor Allergies 98

FDA Law Blog

NOVEMBER 1, 2023

Regulating LDTs: A Long and Winding Road In what might sound to some like protesting too much, the PR invokes FDA’s longstanding assertion that IVDs “manufactured” by laboratories are medical devices and that clinical laboratories that develop tests are acting as manufacturers.

Regulation 81

Regulation In-Vitro Manufacturing Licensing 81

The Pharma Data

MARCH 30, 2021

This press release contains forward-looking statements within the meaning of the United States Private Securities Litigation Reform Act of 1995. These targeted drugs bind to markers or proteins over-expressed by certain tumors, or tumor-associated tissue, such as stroma. Disclaimer. Source link:[link].

Protein 52

Protein Licensing Licensing Containment 52

Druggist

OCTOBER 4, 2020

Limit intake of processed food, which contain difficult to digest starch People who experience episodes of diarrhoea should avoid artificial sweeteners, which can cause a laxative effect. Each single dose sachet of granules contains 3.5g Each single dose sachet of granules contains 3.5g £9.12 Buy on Amazon Price incl.

Containment 98

Containment Pharmacy Bacteria Sales 98

Druggist

FEBRUARY 24, 2021

Individuals who fail to increase their fibre from the diet may consider fibre-containing laxatives or other gentle laxatives available over the counter. . When possible, painkillers containing codeine should be avoided. Each single dose sachet of granules contains 3.5g Each single dose sachet of granules contains 3.5g

Containment 96

Containment Pharmacy Production Sales 96

Druggist

SEPTEMBER 15, 2020

Zovirax cream, marketed as Zovirax Cold Sore Cream, contains 5% of aciclovir. Zovirax cream for cold sores is licensed for the treatment of infections caused by Herpes simplex virus presented on lips or face in children and adults. Generic Zovirax cream for cold sores As previously mentioned, Zovirax cream contains 5% of aciclovir.

Containment 98

Containment Pharmacy Sales Drugs 98

pharmaphorum

JANUARY 20, 2022

The Swiss subsidiary of Glenmark Pharmaceuticals and Lotus International have signed a licensing agreement whereby Glenmark will handle the manufacture and supply of Ryaltris and Lotus will take charge of commercialising the drug, subject to approval.

Allergies 73

Allergies Marketing Production Manufacturing 73

The Pharma Data

AUGUST 17, 2020

Under the agreement, Bristol Myers Squibb will become responsible for the development and any subsequent commercialization of DF6002 and its related products worldwide, including strategic decisions, regulatory responsibilities, funding, and manufacturing. In addition, Dragonfly will receive up to 24% royalties on worldwide net sales.

Licensing 52

Licensing Licensing Development Production 52

Drug Channels

OCTOBER 5, 2021

This 2021-22 edition contains the most current financial and industry data along with detailed information about the strategies and market positions of the largest companies: AmerisourceBergen, Cardinal Health, and McKesson. The 9 chapters are self-contained and do not need to be read in order. pharmaceutical distribution industry.

Licensing 61

Licensing Licensing Containment Drugs 61

Drug Channels

OCTOBER 11, 2022

This 2022-23 edition contains the most current financial and industry data along with detailed information about the strategies and market positions of the largest companies: AmerisourceBergen, Cardinal Health, and McKesson. contains new data on hospital acquisitions and consolidation activity. pharmaceutical distribution industry.

Licensing 55

Licensing Licensing Containment Drugs 55

pharmaphorum

SEPTEMBER 8, 2022

Last year, the company signed two deals in quick succession, which saw it form a licensing deal worth $1.3 This is an important capability because radiopharmaceuticals require just-in-time manufacture and delivery each week. The copper pairing provides significant supply and manufacturing advantages. Different methods.

Manufacturing 97

Manufacturing Development Antibody Drugs 97

FDA Law Blog

JANUARY 3, 2024

CVM does not regulate the practice of veterinary medicine (that’s a state licensing board) or vaccines for animal diseases (that’s USDA). The unapproved drug claims are not, in and of themselves, notable, but it is always interesting when FDA takes a stand against such a large swath of manufacturers and distributors at the same time.

Drugs 59

Drugs Production Licensing Licensing 59

Druggist

APRIL 3, 2021

Codeine containing products , such as co-codamol , may not be the best choice since codeine can cause constipation, possibly aggravating the condition. Contains glyceryl trinitrate (GTN). Anozem 2% cream – contains diltiazem 2%. One over the counter haemorrhoid sprays contains the same combination of active ingredients.

Pharmacy 81

Pharmacy Doctors Doctor Containment 81

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., For more information, please visit www.PAXLOVID.com. .

Drugs 110

Drugs Licensing Licensing Production 110

The Pharma Data

DECEMBER 16, 2020

NASDAQ: AUPH / TSX:AUP) (“Aurinia” or the “Company”) today announced it has entered into a collaboration and license agreement with Otsuka Pharmaceutical Co., All forward-looking information contained in this press release is qualified by this cautionary statement. VICTORIA, British Columbia & ROCKVILLE, Md.–(

Licensing 52

Licensing Licensing Development Sales 52

The Pharma Data

MAY 27, 2022

ViiV Healthcare and MPP are actively negotiating voluntary licensing terms to help widen access to innovative HIV prevention measure .

Medicine 52

Medicine Licensing Licensing Manufacturing 52

XTalks

APRIL 26, 2021

It is the world’s first and only licensed malaria vaccine and also the first licensed for use against a human parasitic disease of any kind. The vaccine is protein-based and contains an adjuvant (MM), a component that helps generate a stronger immune response, that was developed by Novavax.

Vaccination 105

Vaccination Vaccine Immune Response Trials 105

Pharmaceutical Technology

MAY 15, 2023

Pyridine derivatives contain one nitrogen atom in a six-membered aromatic ring and are the most extensively used heterocycles in the field of drug design, due to their promising effect on pharmacological activity, which has led to the discovery of numerous broad-spectrum therapeutic agents.

Antibody 130

Antibody DNA Genome Genomics 130

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

Roots Analysis

FEBRUARY 15, 2022

Given the fact that ADCs are highly potent cytotoxic molecules, the manufacturing of ADCs requires elaborate technical capabilities and highly potent chemical substances. However, several ADC developers do not have the in-house capabilities to manufacture cytotoxic payload on a commercial scale and tend to rely on contract manufacturers.

Contract Manufacturing 52

Contract Manufacturing Manufacturing Marketing Containment 52

Druggist

FEBRUARY 17, 2021

Insect venoms (wasps) contain several allergens, which cause unpleasant symptoms, and in some cases, may cause an anaphylactic reaction (Moffitt, 2003). Hydrocortisone cream which is sold in pharmacies have few restrictions, which reflect the licensing of this medicine: Age restrictions: Adults and children above ten years of age.

Pharmacy 98

Pharmacy Containment Production Sales 98

The Pharma Data

AUGUST 20, 2020

. “The DKd regimen fills an important gap in the treatment landscape, as many patients may relapse following an immunomodulatory drug-based therapy, such as lenalidomide-containing regimens, and therefore new therapeutic options are needed.” Source link.

Licensing 52

Licensing Licensing Containment Regulation 52

Druggist

OCTOBER 30, 2020

When taken in combination with NSAIDs such as ibuprofen, paracetamol has shown to be more effective in pain reduction than combination product containing codeine (Teoh, 2020). In fact, one branded combination products, which contain paracetamol and ibuprofen, is available in the UK.

Containment 64

Containment Pharmacy Production Branding 64

Pfizer

NOVEMBER 2, 2022

The flexibility and manufacturing speed of the mRNA technology has demonstrated that it is well-suited for other respiratory diseases. The vaccine candidate is based on BioNTech’s proprietary mRNA platform technology and contains mRNA strands encoding the wild-type spike protein of SARS-CoV-2 and the spike protein of the Omicron BA.4/BA.5

Vaccination 85

Vaccination Vaccine Clinical Trials Clinical Trials 85

The Pharma Data

NOVEMBER 30, 2020

1, 2020 /PRNewswire/ — Sosei Group Corporation (“the Company”) (TSE: 4565) announces it has entered into a global collaboration and license agreement with Biohaven Pharmaceutical Holding Company Ltd. (“Biohaven”, NYSE: BHVN). . TOKYO and CAMBRIDGE, England , Dec. Sosei Group Forward-looking statements.

Licensing 40

Licensing Licensing Production Development 40

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. In the U.S.,

Vaccination 52

Vaccination Vaccine Manufacturing Containment 52

FDA Law Blog

JUNE 3, 2021

Schlanger — While federal efforts to address prescription drug prices are debated, states have continued to pursue their own measures that require drug manufacturers and other entities in the drug supply chain to disclose information about pricing. By Serra J. See our previous coverage of such state laws here , here and here.) North Dakota.

Development 52

Development Drugs Manufacturing Pharmacy 52

Pfizer

DECEMBER 8, 2022

The vaccine candidate is based on BioNTech’s proprietary mRNA platform technology and contains mRNA strands encoding the wild-type spike protein of SARS-CoV-2 and the spike protein of the Omicron sublineages BA.4/BA.5, The information contained in this release is as of December 9, 2022. COMIRNATY® (COVID-19 Vaccine, mRNA). INDICATION.

Vaccination 81

Vaccination Vaccine Clinical Trials Clinical Trials 81

XTalks

APRIL 24, 2023

Scientific advice meetings with regulators help ensure the trial design and gene therapy manufacturing will meet regulatory expectations. Gene therapies have extensive manufacturing information that is highly technical in nature,” says Walker. “It It needs to be clearly documented with as much information included as possible.”

Gene Therapy 95

Gene Therapy Gene Trials Clinical Trials 95

pharmaphorum

MARCH 26, 2021

The TCA mentions medicinal products only fleetingly in its main body, but contains a specific Medicinal Products Annex. The GMP provisions require the EU and UK to recognise the other’s manufacturing facility inspections and accept its GMP documents. Unfortunately, this is thin gruel. Andrew is also an expert on GDPR.

Production 96

Production Medicine Marketing Regulation 96

Pfizer

FEBRUARY 16, 2023

The companies intend to work with regulatory authorities, and as previously announced, 1,2 aim for Pfizer to potentially submit a Biologics License Application (BLA) to the U.S. Pfizer Disclosure Notice The information contained in this release is as of February 17, 2023.

Clinical Trials 76

Clinical Trials Clinical Trials Vaccination Vaccine 76

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. Disclosure Notice The information contained in this statement is as of January 27, 2023.

Marketing 75

Marketing Production Drugs Licensing 75

The Pharma Data

JANUARY 21, 2021

Spectrum has a strong track record of successfully executing across the biopharmaceutical business model, from in-licensing and acquiring differentiated drugs, clinically developing novel assets, successfully gaining regulatory approvals and commercializing in a competitive healthcare marketplace. SPECTRUM PHARMACEUTICALS, INC.

Clinical Trials 52

Clinical Trials Clinical Trials Licensing Licensing 52