pharmaphorum

SEPTEMBER 21, 2020

Compass Pathways and its potential magic mushroom depression drug went public last week – and now psychedelic therapy firm Mind Medicine is aiming to follow suit by up-listing its shares on the Nasdaq. UK-based Compass has a patented synthetic version of psilocybin, the active ingredient in magic mushrooms, and raised around $127.5

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Medicine FDA Approval Clinical Trials Clinical Trials 134

Pfizer

JULY 8, 2022

FDA Approval of their COVID-19 Vaccine COMIRNATY® For Adolescents 12 through 15 Years of Age. FDA Approval of their COVID-19 Vaccine COMIRNATY® For Adolescents 12 through 15 Years of Age. Pfizer and BioNTech also filed these data with the European Medicines Agency (EMA) and other regulatory authorities around the world.

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FDA Approval Vaccination Vaccine Clinical Trials 102

XTalks

JULY 26, 2024

The US Food and Drug Administration (FDA) has given the green light to Femlyv , a combination oral contraceptive containing norethindrone acetate and ethinyl estradiol. Norethindrone acetate and ethinyl estradiol are legacy drugs that have been approved since 1968 in a swallowable tablet form for the prevention of pregnancy.

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FDA Approval Hormones Containment Drugs 52

Pharmaceutical Technology

FEBRUARY 26, 2023

The idea behind these treatments relies on altering the gut microbiome by designing therapeutics that contain bacteria derived from donated stool samples. In November 2022, Ferring Pharmaceuticals’s Rebyota became the first FDA-approved microbiome-based therapeutic to treat recurrent CDI.

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Bacteria Trials Research Medicine 278

pharmaphorum

JANUARY 12, 2023

Airsupra (PT027), a new asthma rescue treatment developed by AstraZeneca (AZ) and development partner Avillion, has been approved by the US Food and Drug Administration (FDA). Additionally, under its 2018 agreement, Avillion had regulatory responsibility, including filing the New Drug Application (NDA) through to FDA approval.

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FDA Approval Allergies Trials Development 52

Camargo

NOVEMBER 11, 2020

Approval of the Month: Companion Diagnostic for Bayer’s Vitrakvi Should Lead to Improved Patient Outcomes. In November 2017, Foundation Medicine received approval for FoundationOne CDx , a genomic profiling test for solid state tumors, which paved the way for partnerships with pharma companies’ therapeutics.

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Development Bioequivalency Generic Drugs Production 242

XTalks

NOVEMBER 10, 2023

Adzynma is a an ERT containing purified recombinant form of the ADAMTS13 enzyme administered to boost levels of the deficient enzyme in patients with cTTP. Today, we are proud to further support the rare disease community by delivering Adzynma as the first FDA-approved therapeutic option for people with cTTP.”

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FDA Approval Gene Therapy Gene Clinical Trials 59

Pfizer

JULY 19, 2022

Pfizer and BioNTech Complete Submission to European Medicines Agency for Omicron BA.1 Pfizer and BioNTech Complete Submission to European Medicines Agency for Omicron BA.1 is immunocompromised or are on a medicine that affects the immune system. The information contained in this release is as of July 19, 2022.

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Vaccination Vaccine Medicine Clinical Trials 100

XTalks

SEPTEMBER 28, 2023

a Texas-based pharmaceutical firm specializing in psychotropic drug development, revealed that its groundbreaking antidepressant, Exxua (gepirone extended release) for treating major depressive disorder (MDD), received US Food and Drug Administration (FDA) approval on September 22, 2023. Fabre Kramer Pharmaceuticals, Inc.,

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Pharmaceutical Technology

FEBRUARY 8, 2023

Still, Blank suggested that companies enroll the patient population that is most likely to benefit, because early phase studies contain the most safety risks. One such example is Hemgenix (etranacogene dezaparvovec), the first gene therapy to treat adults with haemophilia B, which was approved in November.

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Gene Therapy Gene Trials Clinical Trials 264

pharmaphorum

SEPTEMBER 29, 2021

Amazon is advancing into healthcare on multiple fronts, launching its own pharmacy business for medicines delivery in the US last year, whilst also entering the health wearables market with its own Halo device, and bolstering the health-related capabilities of its Alexa virtual assistant.

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FDA Approval Pharmacy Development Containment 138

pharmaphorum

OCTOBER 2, 2020

UK-based Compass Pathways and its potential magic mushroom depression drug went public last month – and just a week later psychedelic therapy firm Mind Medicine announced it would be up-listing its shares on the Nasdaq. The past few weeks have seen a flurry of companies in this space announce that they intend to go public. .

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Medicine Life Science FDA Approval Development 122

The Pharma Data

NOVEMBER 27, 2020

FDA Approves Imcivree (setmelanotide) for Chronic Weight Management in Patients with Obesity Due to POMC, PCSK1 or LEPR Deficiency. With this approval, Imcivree becomes the first-ever FDA approved therapy for these rare genetic diseases of obesity. BOSTON, Nov. in the first quarter of 2021.

FDA Approval 52

FDA Approval Genetic Disease Genetics Clinical Trials 52

Pharmaceutical Technology

DECEMBER 4, 2022

There are seven FDA-approved Humira biosimilars, of which Amgen’s Amjevita will be launched in January. It is all about what you can get at the lowest cost,” says Dr. Raymond Cross, director of the inflammatory bowel disease program at University of Maryland’s School of Medicine, Baltimore.

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Marketing Pharmacy Production Branding 262

XTalks

DECEMBER 5, 2023

The US Food and Drug Administration (FDA) has granted approval for Bristol Myers Squibb’s (BMS) Augtyro (repotrectinib), marking a significant milestone for the treatment of adult patients with locally advanced or metastatic ROS1 -positive non-small cell lung cancer (NSCLC).

Protein 115

Protein FDA Approval Medicine Trials 115

XTalks

AUGUST 9, 2023

This new medicine is a positive step forward for the treatment of this disease in many patients who have been struggling for years,” said Christopher Starr, MD, associate professor of ophthalmology at Weill Cornell Medicine, New York Presbyterian Hospital, in the company’s press release. What Is Demodex Blepharitis?

FDA Approval 98

FDA Approval In-Vitro Trials Bacteria 98

XTalks

APRIL 29, 2022

Tirzepatide is a novel investigational obesity treatment that contains mimetics of two hormones that are involved in regulating appetite in a single peptide: a GIP (glucose-dependent insulinotropic polypeptide) receptor agonist and a GLP-1 (glucagon-like peptide-1) receptor agonist. percent and 22.5 percent, respectively, compared to placebo.

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Trials Drugs FDA Approval Clinical Trials 98

pharmaphorum

MARCH 4, 2021

billion for its FDA-approved dry eye drug Xiidra during the Japanese pharma’s merger with Shire in 2019, outlining the sales potential in this market niche. Sylentis, part of PharmaMar Group, has just announced FDA approval of a phase 3 trial for eye drops containing tivanisiran, in dry eye disease associated with Sjogren’s Syndrome.

Gene Silencing 98

Gene Silencing FDA Approval Trials Marketing 98

XTalks

DECEMBER 5, 2022

The CBD prodrug will be going up against Jazz Pharma’s Epidiolex, the first FDA approved CBD drug formulation. Approved in 2018, Epidiolex is a CBD oral solution indicated for the treatment of seizures associated with Lennox-Gastaut syndrome and Dravet syndrome, rare and severe forms of epilepsy, in patients two years of age and older.

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Bioavailability FDA Approval Trials Drugs 97

XTalks

AUGUST 6, 2020

The US Food and Drug Administration (FDA) has approved the use of an oral cannabidiol (CBD) solution called Epidiolex for the treatment of seizures associated with tuberous sclerosis complex (TSC) in patients aged one year and older. Epidiolex is the only FDA-approved formulation that contains CBD derived from the cannabis plant.

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FDA Approval Protein Containment Genetic Disease 64

pharmaphorum

OCTOBER 31, 2021

The FDA approval is based on the results of GEMINI 1 and GEMINI 2 studies, which showed that Vuity works as quickly as 15 minutes after dosing with a duration of action of up to six hours, improving near and intermediate vision without affecting distance vision. Brimochol is in phase 2 testing.

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Drugs FDA Approval Trials Development 105

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. Section 351(a) is the traditional pathway for approving biologics under the PHS Act.

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Development Production Immune Response Licensing 161

The Pharma Data

NOVEMBER 2, 2020

Nabiximols is a complex botanical medicine formulated from extracts of the cannabis plant that contains the principal cannabinoids THC and CBD and also contains minor constituents, including other cannabinoid and non-cannabinoid plant components, such as terpenes, sterols and triglycerides, according to company data.

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FDA Approval Drugs Marketing Botox 52

The Pharma Data

MARCH 30, 2021

In Europe, KEYTRUDA is approved for the treatment of adult patients with advanced or metastatic urothelial carcinoma (bladder cancer) who are not eligible for cisplatin-containing chemotherapy and whose tumors express PD-L1 with a Combined Positive Score (CPS) ?10. 1] as determined by an FDA-approved test.

FDA Approval 52

FDA Approval Containment Trials Genome 52

The Pharma Data

JULY 8, 2021

One of the world’s first global biotechnology companies, Biogen was founded in 1978 by Charles Weissmann, Heinz Schaller, Kenneth Murray and Nobel Prize winners Walter Gilbert and Phillip Sharp. For more information about Eisai Co., please visit [link]. Biogen Safe Harbor.

Clinical Trials 52

Clinical Trials Clinical Trials FDA Approval Trials 52

pharmaphorum

OCTOBER 31, 2022

It is the first FDA-approved treatment for Zaire ebolavirus. Yancopoulos continued: “Our scientists realised that the science demanded they adapt these technologies to deliver the first FDA-approved recombinant monoclonal antibody treatment for any viral disease, and they picked one of the most challenging ones in Ebola.”.

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Production FDA Approval Antibody Gene 52

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

Licensing 52

Licensing Licensing Vaccination Vaccine 52

Advarra

JULY 26, 2022

with 37 states approving medicinal use and 18 approving recreationally. Cannabis plants and derivatives containing no more than 0.3% Cannabis and cannabis-derived compounds are treated the same as other FDA-regulated products and subject to the same authorities and requirements.

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Regulation Research Production Cosmetics 97

XTalks

MAY 17, 2024

The settlement requires Totality to take several specific corrective actions, which include refraining from making any statements that suggest the spa’s products are genuine, FDA-approved Lilly products, and stopping the use of Eli Lilly branding in promoting any of the products.

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Sales FDA Approval Pharmacy Production 52

Camargo

DECEMBER 10, 2021

Biomarin’s stock shot up after the drug was first approved in the EU this past August, and on the day the news broke of the FDA approval, the stock improved 10.3%. While the value of these vouchers has declined in recent years, they are still worth $67-$350 million, per the most recent GAO report.

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Development Genetics Production Clinical Trials 176

XTalks

DECEMBER 26, 2022

has obtained US Food and Drug Administration (FDA) approval of an expanded indication for the use of Cytalux (pafolacianine) for the detection of lung cancer during surgery. On Target Laboratories, Inc. This biotech company discovers and develops targeted intraoperative molecular imaging agents to illuminate cancer during surgery.

FDA Approval 52

FDA Approval Drugs Clinical Trials Clinical Trials 52

Pharmaceutical Technology

MAY 4, 2023

The approval comes after an FDA Vaccines and Related Biological Products Advisory Committee (VRBPAC) unanimously voted in support of Arexvy’s effectiveness and safety. These recommendations and the FDA approval were based on positive AReSVi-006 Phase III trial data. against RSV-LRTD in adults ages 60 years and over.

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Vaccination Vaccine Trials FDA Approval 162

The Pharma Data

JUNE 17, 2022

Sandoz, a global leader in generic and biosimilar medicines, today announced that the European Medicines Agency (EMA) has accepted the application for high concentration formulation 100 mg/mL (HCF) of its biosimilar Hyrimoz ® (adalimumab) for regulatory review. Our ambition is to be the world’s leading and most valued generics company.

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Medicine Generic Pharmaceutical FDA Approval Packaging 52

pharmaphorum

APRIL 27, 2021

On Wednesday (28 April), the focus will shift to Keytruda and Tecentriq as first-line treatments for UC patients unable to be treated with cisplatin-containing chemotherapy – which got the go-ahead in 2017 and 2018, respectively.

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Drugs Trials FDA Approval Marketing 90

The Pharma Data

DECEMBER 17, 2020

NASDAQ: REGN ) today announced that the New England Journal of Medicine (NEJM) has published initial clinical data from an ongoing seamless Phase 1/2/3 trial of the antibody cocktail casirivimab and imdevimab in non-hospitalized patients with COVID-19. Casirivimab and imdevimab injection is not FDA approved for any use.

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Antibody Medicine Production Trials 52

XTalks

APRIL 27, 2021

With the authorization, the IpsiHand System becomes the first non-invasive neurological rehabilitation device to receive FDA approval in the rapidly growing brain-computer interface space. The headset records brain activity on the side of the brain that is not affected by stroke.

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Radiology Development FDA Approval Containment 105

Delveinsight

OCTOBER 1, 2021

Myasthenia Gravis Approved Therapies. The current Myasthenia Gravis therapeutics market has many FDA-approved drugs for the treatment of Myasthenia Gravis. Some of the approved drugs are: Prograf (Tacrolimus). Prograf is available for oral administration in the form of capsules (tacrolimus capsules USP) containing 0.5

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Marketing Antibody Drugs Sales 85