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Tag: distribution


News

Ensuring Contractors Perform Good Distribution Practices

March 1, 2024

Via: Biopharm International

The number of contractors and subcontractors involved in the supply chain for finished goods can be high, and their relationships very complex, particularly when goods are shipped by air or sea. Depending on the scope of the activity (e.g., whether […]


Biotech, Industry

Arch, a prolific biotech creator, is raising $3B for startup investing

February 2, 2024

Via: Biopharma Dive

Arch Venture Partners, one of the biotechnology sector’s most prolific company creators, is raising a new $3 billion fund, according to a regulatory filing. The fund, which would be Arch’s 13th, is being put together less than two years after […]


FDA, Regulations

FDA Grants Orphan Drug Designation to First-in-Class Treatment for Eosinophilic Esophagitis

January 31, 2024

Via: Biopharm International

Revolo Biotherapeutics announced on Jan. 30, 2024 that FDA has granted Orphan Drug Designation to ‘1104, a first-in-class immune-resetting peptide being developed as a potential treatment for eosinophilic esophagitis (EoE). Revolo focuses on developing therapies that reset the immune system […]


FDA, Regulations

5 FDA decisions to watch in the first quarter

January 4, 2024

Via: Biopharma Dive

Biotechnology is often described as an “innovation” industry, dependent on companies’ ability to invent and develop new medicines. By that metric, 2023 was a good year. The FDA’s main review office approved 55 novel drugs, the most since 2018, while […]


Cell and Gene Therapy, Industry

Novartis deepens ties with Voyager via $100M gene therapy deal

January 2, 2024

Via: Biopharma Dive

Novartis is a leading gene therapy developer. In 2019, its SMA treatment Zolgensma became one of the first genetic medicines cleared for use in the U.S., and so far has been the field’s most lucrative product. Since then, gene therapy […]


Biotech, Industry

‘It’s felt like Groundhog Day’: Biotech IPO slump drags on through 2023

July 6, 2023

Via: Biopharma Dive

Initial public offerings in the biotechnology sector have been occuring at a snail’s pace in 2023, prolonging a downturn that’s now lasted nearly two years. Since January, only nine biotech companies have gone public, putting new stock offerings in the […]


FDA, Regulations

With spotlight on FDA, Congress weighs reforms to accelerated drug approvals

May 10, 2022

Via: Biopharma Dive

Over the past few years, the Food and Drug Administration has come increasingly under scrutiny for its program to grant speedy approvals to drugs that show early signs of benefiting patients with life-threatening diseases. These so-called accelerated approvals have ushered […]


FDA, Regulations

No go for Zosano as FDA knockback triggers suspension of transdermal migraine patch program

May 3, 2022

Via: FiercePharma

Zosano Pharma’s headaches are intensifying. With the FDA again knocking back its transdermal migraine patch, the biotech has suspended its M207 program and made more layoffs to preserve its dwindling cash reserves. The patch uses microneedles to deliver zolmitriptan, a […]


Pricing, Regulations

With D.C. drug pricing talks up in the air, the ‘endgame’ could still ‘have a bite,’ analyst says

October 6, 2021

Via: FiercePharma

With Democrats in Washington debating the specifics of the president’s infrastructure program, the pharmaceutical industry may be able to squeak out a much-desired drug pricing win. As the negotiations unfold, Politico reports that the party leadership may have to abandon […]


Industry, Vaccines

With FDA verging on its first COVID booster approval, Pfizer and Moderna will have to recalibrate revenues—again

August 12, 2021

Via: FiercePharma

Pfizer and Moderna are getting used to readjusting their projected COVID-19 vaccine sales. Now another recalibration may be in order. The FDA is set to authorize a third dose of their COVID-19 shots for those with weakened immune systems, NBC […]


Clinical Trials, Research and Development

Integrating sourcing, packaging, labelling and distribution for efficient clinical kitting

July 19, 2021

Via: Biopharma Dive

Efficient execution of clinical trials requires the provision of medicines and all other critical materials to be carefully delivered on time to clinical sites or patient’s homes. Undertaking this level of detail at scale requires a considerable range of resources, […]


Manufacturing, Research and Development

After COVID-19 spotlighted supply chain weaknesses, Biden unveils plan to resurrect U.S. drug manufacturing

June 8, 2021

Via: FiercePharma

After investigating America’s supply chains, including those for drugs and pharmaceutical ingredients, the Biden administration has revelations to share—and it’s proposing a sweeping strategy to boost domestic drug production. Under the plan, the White House is establishing a public-private partnership […]


Industry, Pharma

Pharma delivers: New campaign celebrates pharma distribution companies’ role during pandemic

June 4, 2021

Via: FiercePharma

Most people don’t normally think about the intricacies of the pharma supply chain, but the COVID-19 pandemic suddenly pushed the topic front and center. Now a new ad campaign from the Healthcare Distribution Alliance celebrates the critical work of healthcare […]


FDA, Regulations

AngioDynamics Submits 510(k) Application to FDA for AlphaVac Mechanical Thrombectomy System

April 12, 2021

Via: BioSpace

AngioDynamics, Inc. (NASDAQ: ANGO), a leading provider of innovative, minimally invasive medical devices for vascular access, peripheral vascular disease, and oncology today announced that on April 9, 2021, it submitted a 510(k) application to the United States Food and Drug […]


Manufacturing, News, Research and Development

Pharmaceutical Contract Development and Manufacturing Market | Exclusive Report on the Latest Trends and Market Revenues

April 8, 2021

Via: BioSpace

The rising popularity of outsourcing implementations across the healthcare industry due to the benefits such as affordability and less-time consumption will serve as a vital growth prospect for the pharmaceutical contract development and manufacturing market during the forecast period of […]


News

Agena Bioscience Signs Exclusive Distribution Agreement with AGBL Group of Companies

March 10, 2021

Via: BioSpace

Agena Bioscience, the global manufacturer of the MassARRAY System for targeted genetic analysis, announced an exclusive distribution agreement with Alliance Global, the AGBL Group of companies, to bring the MassARRAY technology to many emerging markets across the Middle East, Africa, […]


News

Clash Over FDA’s Top Lawyer Appointees Causes Further Discord Between Agency and HHS

January 12, 2021

Via: BioSpace

The U.S. Food and Drug Administration (FDA) is experiencing abrupt and noticeable personnel changes as it continues to clash with the Health and Human Services (HHS), the department that oversees the agency and its operations. As reported in POLITCO, the […]


Industry, Pharma

Algernon Pharmaceuticals Announces Acceleration of Expiry Date of Warrants

December 24, 2020

Via: BioSpace

Algernon Pharmaceuticals Inc. (CSE: AGN) (FRANKFURT: AGW) (OTCQB: AGNPF) (the “Company” or “Algernon”) a clinical stage pharmaceutical development company announces that the Company has elected to exercise its acceleration right under the warrant indenture (the “Indenture”) governing the common share […]


Clinical Trials, Industry, Manufacturing, Research and Development, Vaccines

Vaccine production in focus as Moderna, Pfizer await FDA decision

December 4, 2020

Via: Biopharma Dive

With Pfizer’s and Moderna’s vaccines proving highly protective against COVID-19 in large clinical trials, planning to roll out and distribute the two shots throughout the U.S. has kicked into high gear. The vaccines are expected to be authorized shortly after […]


FDA, Regulations

5 FDA approval decisions to watch in the 4th quarter

September 29, 2020

Via: Biopharma Dive

The next three months will be among the most consequential in the Food and Drug Administration’s modern history. This fall, at least two of the leading coronavirus vaccine makers could seek emergency approvals, setting up what will be a series […]