Top

Tag: distribution


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 […]


Clinical Trials, Manufacturing, Research and Development

CNS Pharmaceuticals Announces US Drug Manufacturing Milestones

September 3, 2020

Via: BioSpace

CNS PHARMACEUTICALS AG, Inc. (NASDAQ: CNSP) (“CNS” or the “Company”), a biopharmaceutical company specializing in the development of novel treatments for primary and metastatic cancers of the central nervous system, today provides an update on progress for the U.S. manufacturing […]


Industry, Vaccines

AstraZeneca nets $396M down payment from EU for 300M-plus COVID vaccines

August 28, 2020

Via: FiercePharma

AstraZeneca has been on roll lately, inking COVID-19 vaccine supply deals left and right with countries worldwide. One of its highest-profile pacts—a purchase deal with the European Union—was made official earlier this month, and now, the trading bloc has floated […]


Pricing, Regulations

Trump invites high-stakes showdown with big pharma as election looms

July 28, 2020

Via: Biopharma Dive

With just over three months before the U.S. elections in November, President Donald Trump is making a last-ditch effort to stamp his name on a drug pricing deal that has eluded him over his first three years in office. A […]


Industry, Vaccines

U.S. Official: COVID-19 Vaccine Manufacturing Could Begin By Late Summer

July 14, 2020

Via: BioSpace

In hopes of a late-stage COVID-19 vaccine candidate hitting the 50% efficacy threshold set by the U.S. Food and Drug Administration, U.S. drugmakers who have partnered with the U.S. government could begin to manufacture doses of a preventative treatment by […]


Industry, Vaccines

EU proposes countries band together to buy coronavirus vaccines

June 17, 2020

Via: Biopharma Dive

Vaccines normally take years to test and mass produce; the European Union, like the U.S., is trying to shrink that timeframe to 12 to 18 months. In addition to providing financial help to companies who are ramping up production before […]


FDA, Regulations

FDA Revokes EUA for Hydroxychloroquine

June 15, 2020

Via: Biopharm International

FDA has revoked the emergency use authorization (EUA) for hydroxychloroquine sulfate (HCQ) and chloroquine phosphate (CQ) as treatments for COVID-19, according to a June 15, 2020 announcement. In a statement on its website, the agency noted that it “has determined […]