Pharma in Brief

DECEMBER 3, 2023

This year marks the 30-year anniversary of the Patented Medicines (Notice of Compliance) Regulations ( Regulations ), introduced in 1993 to prevent patent infringement by linking the regulatory approval of generic or biosimilar drugs with the patent rights of innovators. Evolution of the Regulations Coming into force (1993–1997).

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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 . Widening access for an injectable such as this is complex and will take all stakeholders playing their part. These are challenges not only for ViiV Healthcare but also for any future generic licensees.

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Pharmaceutical Technology

MAY 24, 2023

It is also licensed by Spain’s Centro de Investigación Biomédica en Red de Enfermedades Raras, the Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz and the Centro de Investigaciones Energéticas, Medioambientales y Tecnológicas. The therapy has also received orphan drug and fast-track designations.

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FDA Law Blog

JANUARY 3, 2024

Enter the FDA’s Center for Veterinary Medicine (“CVM”). CVM does not regulate the practice of veterinary medicine (that’s a state licensing board) or vaccines for animal diseases (that’s USDA). So, much like humans, pets are living longer and facing the ailments so common to old age.

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Delveinsight

AUGUST 17, 2021

Food and Drug Administration gave a red flag to FibroGen’s anemia pill roxadustat, for the use in patients suffering from kidney diseases owing to safety concerns that arose after results, which in turn are concluded for the presentation of further clinical studies to assess safety for future medicinal use.

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The Pharma Data

MARCH 30, 2021

Targeted radioligand therapy is a type of precision medicine combining two key elements: a targeting compound, or ligand, and a radioactive isotope, causing DNA damage that inhibits tumor growth and replication. We believe this technology has the potential to transform many patients’ lives.”. Disclaimer. Source link:[link].

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Druggist

JULY 22, 2020

Promethazine, however, is included in some liquid medicines , which are used to relieve symptoms of colds and influenza at night , alongside other active ingredients, which together help with the management of coughs. All products listed above are licensed as pharmacy only medicines – ‘P’ products.

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Drug Discovery World

APRIL 11, 2024

The Scottish Medicines Consortium (SMC) has accepted GSK’s dostarlimab as a treatment for adult patients with endometrial cancer when used in combination with platinum-containing chemotherapy. This means that dostarlimab is the first immunotherapy treatment to be accepted for use within NHS Scotland for this group of eligible patients.

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Drug Discovery World

JULY 3, 2023

PrecisionLife and the University of Oxford have signed a data access agreement to license the Oxford Endometriosis Gene (OXEGENE) dataset to develop new personalised treatments for endometriosis patients. We hope that the analysis of our data will lead to the development of precision medicines to improve the lives of patients.”

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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., The Pfizer-BioNTech COVID-19 Vaccine has not been approved or licensed by the U.S. The information contained in this release is as of May 7, 2021.

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Drug Discovery World

MAY 5, 2023

The deal also provides Eterna with an exclusive global license to produce an unlimited number of mRNA-engineered natural killer (NK) and T-cell therapies derived from induced pluripotent stem cells (iPSCs). “We We are excited to bring this powerful platform into Eterna.

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Druggist

AUGUST 3, 2020

Otrivine Extra Dual Relief is a pharmacy only medication and the only over the counter product containing ipratropium bromide for the management of congestion and runny nose caused by colds. P medicines can only be purchased from a pharmacy, including an online pharmacy with a presence of a pharmacist. Do you take any medicines?

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pharmaphorum

MAY 4, 2022

There are existing alternatives, with one being human cell culture systems, which provide an environment that is closer to that which will eventually receive treatment but do not contain the complexity of a complete organism. Organ-on-a-chip. Nascent technology.

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The Pharma Data

DECEMBER 13, 2020

RLY-1971 is a potent small molecule inhibitor of Src homology region 2 domain-containing phosphatase-2 (SHP2). Relay Therapeutics (Nasdaq: RLAY) is a clinical-stage precision medicines company transforming the drug discovery process with the goal of bringing life-changing therapies to patients. . CAMBRIDGE, Mass., About RLY-1971.

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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.

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Druggist

FEBRUARY 28, 2021

Is melatonin effective sleep aid medicine? 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. Despite this well-defined licensed use, Circadin is very often prescribed off-license to children and adolescents. 1,640 Reviews.

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Druggist

NOVEMBER 1, 2020

Lidocaine patch (brand name: Versatis medicated plaster) is a prescription-only medication, which has limited licensed use in the UK. The UK licensed use of lidocaine Can you use lidocaine patch for back pain? As the name suggests, lidocaine patch is a medicated plaster which contains a local anaesthetic – lidocaine 5%.

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The Pharma Data

AUGUST 17, 2020

Bristol Myers Squibb is a global biopharmaceutical company whose mission is to discover, develop and deliver innovative medicines that help patients prevail over serious diseases. DF6002 is the most advanced in a pipeline of cytokines that Dragonfly is developing to address the high unmet need in patients with advanced cancer.

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Drug Discovery World

AUGUST 9, 2023

The UK Medicines and Healthcare products Regulatory Agency (MHRA) has granted Aleta Biotherapeutics a clinical trial authorisation (CTA) to evaluate biologic ALETA-001 in a Phase I/II clinical trial in patients with B-cell malignancies who are relapsed/refractory to CD19 CAR T cell therapy.

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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. . What is Celevac?

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Camargo

NOVEMBER 11, 2020

Unpacking the (Black) Box: Antares Licenses Urology Product with Boxed Warning. In October, Antares Pharma licensed Ferring Pharmaceuticals’ Nocdurna® (desmopressin acetate) sublingual tablet , which was approved in 2018 for the same indication as Noctiva and has a boxed warning highlighting the same risks.

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Druggist

APRIL 3, 2021

Diltiazem cream (diltiazem hydrochloride cream) is a medicine prescribed in the UK to manage chronic anal fissure. Calcium channel blockers are a group of medicines used mainly in the management of high blood pressure and angina. Contains glyceryl trinitrate (GTN). Anozem 2% cream – contains diltiazem 2%.

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Druggist

JANUARY 9, 2021

Where possible, I will review the evidence to answer what the best over the counter migraine medicine is. Over the counter codeine-based medicines. Smaller packs of paracetamol (contain 16 tablets or capsules) are available in all supermarkets and pharmacies for patient self-selection. Over the counter sumatriptan for migraine.

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Druggist

JULY 15, 2020

Information reviewed in this post: Legal status and availability of Disprin Licensed use Age restrictions Contra-indications: who cannot use Disprin chewable aspirin Recommended dose Possible side-effects Alternative options Disprin Direct legal status The legal status of Dispirin Direct depends on the pack size of the product.

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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.

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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.–(

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The Pharma Data

OCTOBER 29, 2020

Tokyo, Japan) today announced that the European Medicines Agency (EMA) has confirmed it has accepted for review, following a standard timetable, the Marketing Authorization Application (MAA) for aducanumab, an investigational treatment for Alzheimer’s disease. CAMBRIDGE, Mass. and TOKYO, Oct. Since October 2017 Biogen and Eisai Co.,

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Druggist

MAY 16, 2021

Each adult form of paracetamol, for example, a tablet or capsule, contain 500mg of paracetamol. Paracetamol for children over six years of age comes at a concentration of 250mg/5ml of oral solution, which means that each 5ml oral solution contains 250mg of paracetamol. Unlike tablets, in capsule form drug is contained in a shell.

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Camargo

DECEMBER 13, 2021

The development of biological products (or biologics) represents a major advancement in modern medicine, enabling the treatment of patients with many illnesses where no other therapeutics were previously available. The regulations regarding BLAs for therapeutic biological products are included in 21 CFR parts 600 , 601 , and 610.

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The Pharma Data

APRIL 27, 2023

About GSK’s RSV older adult vaccine candidate GSK’s RSV older adult vaccine candidate contains a recombinant subunit RSV prefusion F glycoprotein antigen (RSVPreF3) combined with the Company’s proprietary AS01 E adjuvant. Additional regulatory submissions will continue throughout this year. These were typically mild to moderate and transient.

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Druggist

JANUARY 15, 2021

Paracetamol, one of the most prescribed drugs in the UK , and probably the most popular over the counter medicine has been recently subject to shortages due to increased demand in recent months. Firstly, I will list some common combination of drugs, which contain paracetamol, which may be used if standard paracetamol tablets or capsules.

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Pfizer

SEPTEMBER 27, 2022

We’re proud to be strengthening our capacity to develop and produce more advanced medicines that can help improve the lives of patients. This investment supports both Wisconsin’s economy and patient access to the medicines they need. The Pfizer-BioNTech COVID-19 vaccine has not been approved or licensed by the U.S. Global Goals.

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Druggist

NOVEMBER 19, 2020

As we already learned from the above combination inhaler in asthma contains two ingredients, one of which is inhaled corticosteroid and the other LABA. The Medicines and Healthcare products Regulatory Agency (MHRA) recommends that LABA should always be taken with inhaled corticosteroids. What is a combination inhaler? Price incl.

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Pfizer

SEPTEMBER 27, 2022

Embodied by our “Science Will Win” campaign, Pfizer is at the forefront of the vital research being conducted to find treatments, cures and preventive medicines to the diseases that currently confound us. Pfizer and BioNTech Complete Submission to European Medicines Agency for Omicron BA.4/BA.5-Adapted Medicines, Research.

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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.

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XTalks

DECEMBER 20, 2021

It has also applied for regulatory licensing in the UK, European Union (EU), Australia, Singapore, India, United Arab Emirates (UAE), New Zealand and Japan. It contains Novavax’s Matrix-M adjuvant to enhance the immune response. The full study results were published last week in the New England Journal of Medicine (NEJM).

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The Pharma Data

MAY 4, 2021

Lilly is offering donations of baricitinib to the Indian government through Direct Relief while simultaneously working with local Indian pharmaceutical companies to execute royalty-free voluntary licensing agreements to accelerate the manufacturing and distribution of the medicine in India during the pandemic. BA HCP ISI 09JUL2020.

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