Pharmaceutical Technology

FEBRUARY 8, 2023

The top 20 companies in the global biopharma industry saw 5.4%* aggregate market capitalization from $3.43 The biopharma industry continues to remain resilient while facing mounting pressure on drug pricing and a downturn in demand for COVID-19 therapies. trillion to $3.61 to $365.84.

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Pharmaceutical Technology

FEBRUARY 16, 2023

The US Food and Drug Administration (FDA) has accepted the biologics licence application (BLA) for Shanghai Henlius Biotech ’s proposed biosimilar HLX02 (trastuzumab for injection). Accord BioPharma (Accord US), the business partner of Shanghai Henlius Biotech, has submitted the BLA.

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European Pharmaceutical Review

JULY 17, 2023

The $82 million project is funded by the US Food and Drug Administration (FDA) Center for Biologics Evaluation and Research. The research team will work with the FDA to make sure the pilot-scale system aligns to current good manufacturing practices (cGMP) and informs regulatory strategies.

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European Pharmaceutical Review

AUGUST 31, 2023

American Point Biopharma owns proprietary radiopharmaceutical manufacturing facilities and maintains active relations with further manufacturers. FDA approves new treatment for certain digestive tract cancers [Internet]. FDA approves Pluvicto for metastatic castration-resistant prostate cancer [Internet]. Point Biopharma.

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pharmaphorum

JANUARY 9, 2023

Biopharma and healthcare group Chiesi Farmaceutici S.p.A. The development is for expansion of the company’s in-house drug development of biologicals and rare disease targeting and the site is due to become operational from 2024, with FDA, IFA, and EMA approvals due to be sought for 2025. in an all-cash transaction at $14.50

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Pharmaceutical Technology

APRIL 4, 2023

The Boston, Massachusetts-based Scorpion expects to submit an investigational new drug (IND) application for STX-721 to the US Food and Drug Administration (FDA) in mid-2023, with an IND application for STX-241 expected in H1 2024. The biopharma aims to start the study as soon as the IND is cleared by the FDA.

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Pharmaceutical Technology

JANUARY 31, 2023

FDA director Robert Califf gave his prognosis for the pharma industry at this year’s JP Morgan Healthcare Conference in San Francisco over January 9–12. This “skinny” bill passed just in time to continue funding the FDA, with few of the planned amendments. billion in funding, a $226 million increase on the previous year.

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PM360

MAY 2, 2023

We are fortunate to work with innovative startup and mid-stage biopharma companies that are developing vaccines and medicines for rare diseases, cancer, specialty therapeutic areas, and other patient needs, as well as partnering with diagnostic and medical device companies.

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European Pharmaceutical Review

JANUARY 24, 2023

Takeda has entered into an exclusive licensing agreement with biopharma HUTCHMED, to develop and commercialise t yrosine kinase inhibitor fruquintinib, refractory metastatic colorectal cancer (CRC) for outside of mainland China, Hong Kong and Macau. The agreement is valued up to $1.13 This is planned to be completed in the first half of 2023.

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European Pharmaceutical Review

JULY 20, 2023

More recently, the FDA granted approval of Roctavian in June 2023. Moving the discussion on, Alex Bloom, Chief Technology Officer of AviadoBio declared: “Thinking whether you change is inevitable in biopharma, particularly for cell and gene therapy, where we are just not mature on the technology curve.”

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Pharmaceutical Technology

MAY 15, 2023

The US FDA database has 95 approved pyridine derivatives, including isoniazid and ethionamide (tuberculosis), delavirdine (HIV/AIDS), abiraterone acetate (prostate cancer), and tacrine (Alzheimer’s).

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PM360

DECEMBER 14, 2023

With its new funding, the company is developing a roadmap to an overall goal of automating the entire document process across pharma, from preclinical trials all the way through FDA approval. The company’s enterprise software platform, Yseop Copilot, leverages pre-trained large language models (LLM) built for the biopharma industry.

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MedCity News

OCTOBER 15, 2023

The FDA’s digital health advisory committee will discuss technologies such as artificial intelligence and machine learning, virtual reality, and digital therapeutics as well as topics like decentralized clinical trials and patient-generated health data. Committee member nominations are due in December.

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MedCity News

NOVEMBER 7, 2023

The Federal Trade Commission says more than 100 patents from 10 biopharma companies are improperly listed in the FDA’s official publication of approved products. Such listings delay generic competition, which reduces consumer choice and keeps prices high, the regulator said.

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MedCity News

OCTOBER 18, 2023

FDA approval of UCB’s Bimzelx gives the Belgian drugmaker a contender in the crowded plaque psoriasis therapies market. In the rare disease generalized myasthenia gravis, the agency approved Zilbrysq, a UCB drug with advantages over two blockbuster AstraZeneca drugs addressing the same target.

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MedCity News

SEPTEMBER 27, 2023

NurOwn, Brainstorm Cell Therapeutics’ experimental stem cell therapy for ALS, did not win the backing of an independent panel of FDA advisors. Many advisory committee members said they want to see more data from another clinical trial, the same guidance the FDA has given the biotech for nearly three years.

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MedCity News

SEPTEMBER 11, 2023

The FDA said the updated messenger RNA vaccines from Pfizer/BioNTech and Moderna will protect against the omicron subvariants now prevalent in circulation. Left out of the FDA decision is Novavax, whose protein-based vaccine is still under regulatory review.

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MedCity News

OCTOBER 13, 2023

Pfizer’s new FDA-approved ulcerative colitis drug Velsipity comes from its $6.7 billion Arena Pharmaceuticals acquisition. The small molecule will compete against blockbuster Bristol Myers Squibb drug Zeposia, which addresses the same target.

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MedCity News

OCTOBER 3, 2023

Novavax’s updated version of its Covid-19 vaccine is now FDA authorized for use in the U.S., joining the approved shots from Moderna and partners Pfizer and BioNTech. Novavax said its protein-based vaccine will be available in coming days.

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MedCity News

MAY 11, 2023

The FDA decision makes the Otsuka Pharmaceutical and Lundbeck product the first drug approved for this indication. Rexulti, a drug for schizophrenia and depression, now has an additional approval for treating agitation in Alzheimer’s disease patients.

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MedCity News

JANUARY 13, 2023

The FDA approved a change in Rybelsus’s label, allowing the drug to be used as an initial therapy for type 2 diabetes patients. The once-daily pill has already become a blockbuster product for Novo Nordisk.

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MedCity News

JANUARY 5, 2023

Fewer new drugs won FDA approvals in 2022 compared to previous years, but some of the products that passed regulatory muster are indicative of trends expected to continue into 2023. For example, more gene and cell therapies are on track to face regulatory decisions in the coming year.

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MedCity News

SEPTEMBER 25, 2023

Scynexis said no adverse events or contamination problems have been reported for Brexafemme, an antifungal approved for treating vaginal yeast infections. The biotech said the risk of cross-contamination stems from the processes of the small molecule’s third-party manufacturer.

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MedCity News

APRIL 20, 2023

Over the past 2 years, concerted efforts have been undertaken by policymakers and FDA’s Oncology Center of Excellence to mitigate risks and improve the transparency of the accelerated approval program. These actions are crucial to restoring public trust – trust that has suffered considerable erosion.

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MedCity News

OCTOBER 8, 2023

Takeda Pharmaceutical drug Exkivity failed the confirmatory study required of its 2021 accelerated approval. Our recap of other recent regulatory developments includes a partial clinical hold on a cancer drug, a Covid-19 vaccine authorization, and several drug approvals in the U.S. and beyond.

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MedCity News

DECEMBER 19, 2023

Chiesi Group’s Filsuvez is the second drug to win FDA approval for epidermolysis bullosa and the first for junctional EB, a more severe form of the rare skin disease. The birch tree bark-derived drug is from Chiesi’s $1.25 billion Amryt Pharma acquisition.

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MedCity News

FEBRUARY 17, 2023

FDA approval of the Chiesi drug comes about five years after European regulators authorized the product. Chiesi drug Lamzede is an engineered version of an enzyme that’s lacking in patients with the rare disease alpha-mannosidosis.

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MedCity News

DECEMBER 28, 2023

The FDA said promethazine hydrochloride, a generic drug used to manage allergies and motion sickness, should be administered by intramuscular injection. Intravenous injection can cause chemical irritation and tissue damage, an FDA alert states.

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MedCity News

JANUARY 25, 2023

The FDA is trying to tell these companies what it wants to be different in trials across the board with regards to digital health endpoints, the use of real-world data (RWD) as regulatory-grade data, and diversity in clinical trial inclusion. The agency’s goal is to spur a macro shift in clinical trials.

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MedCity News

NOVEMBER 28, 2023

CAR T-therapies for cancer are now under tighter FDA scrutiny as the agency opens an inquiry regarding reports that some patients who received these cell therapies went on to develop new cases of cancer. The FDA said benefits of these therapies still outweigh their risks, but it is evaluating the need for regulatory action.

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MedCity News

SEPTEMBER 17, 2023

FDA approval of GSK’s Ojjaara in myelofibrosis introduces a new competitor to blockbuster Incyte drug Jakafi. Ojjaara was part of GSK’s $1.9 billion acquisition of Sierra Oncology last year.

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MedCity News

MAY 25, 2023

Paxlovid, a Pfizer antiviral awarded FDA emergency authorization in 2021 for treating Covid-19, is now approved for treating adults. Results from a pivotal clinical showed that Paxlovid led to an 86% reduction in Covid-19-related hospitalization or death from any cause compared to a placebo.

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MedCity News

JUNE 1, 2023

Pfizer’s Abrysvo is now approved for preventing illness caused by respiratory syncytial virus, or RSV, in adults 60 and older. The regulatory decision comes weeks after GSK won approval for its RSV vaccine, Arexvy.

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MedCity News

NOVEMBER 8, 2023

Eli Lilly weight management drug Zepbound landed its much anticipated FDA approval. The new Lilly product is in the same drug class as Novo Nordisk weight medication Wegovy, but it offers an additional mechanism of action and costs less.

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MedCity News

MAY 18, 2023

FDA approval of blockbuster AbbVie drug Rinvoq makes it the first oral therapy for moderately to severely active Crohn’s disease. The regulatory nod is the seventh for the drug, which belongs to a class of therapies called JAK inhibitors.

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MedCity News

MAY 19, 2023

Bausch + Lomb drug Miebo is now FDA approved as a new treatment for dry eye disease. Unlike many products that rewet the eye, Miebo is designed to address one of the factors that leads to dry eyes.

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MedCity News

JULY 2, 2023

CellTrans’s Lantidra is now the first FDA-approved cell therapy for type 1 diabetes. The therapy is made from islet cells sourced from deceased donors.

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