The Astrazeneca plc and Oxford University phase III trial of their adenovirus-based coronavirus vaccine is back up and running in the U.K. after a week’s worth of study and decision-making. Details on the illness prompting the halt are being held close to the vest by investigators. Astrazeneca and Oxford, the trial sponsor, said they cannot disclose what they termed “further medical information.” The study of AZD-1222 resumed with the blessing of the U.K.’s Medicines Health Regulatory Authority on Sept. 12 after a Sept. 6 standard review prompted the voluntary halt. During the pause, independent committees and international regulators pored over the safety data, concluded the trial was safe and passed their findings to the regulatory authority.

$21B acquisition of Immunomedics strengthens Gilead’s oncology portfolio

In the company’s largest ever acquisition, Gilead Science Inc.’s deal to buy Immunomedics Inc. for $21 billion substantially transforms Gilead’s oncology portfolio. The massive deal that has some analysts and investors cocking their heads at the high cost that brings Gilead Trodelvy (sacituzumab govitecan-hziy), a trophoblast antigen2 directed antibody-drug conjugate that received the FDA’s accelerated approval in April for treating triple-negative breast cancer in patients who have undergone at least two prior therapies. Gilead has spent a lot of time and money in the past two years to strengthen its oncology portfolio by completing 12 deals. Gilead stock (NASDAQ:GILD) was up 3% at midday but Morris Plains, N.J.-based Immunomedics shares (NASDAQ:IMMU) far outpaced it by soaring 100%.

Seagen nails pair of sweet deals with Merck for ADC prospect Tukysa

The pair of whopping contracts signed by Seattle Genetics Inc. (Seagen) with Merck & Co. Inc. starts with the pharma giant buying a $1 billion stake in Seagen. One arrangement involves worldwide development antibody-drug conjugate ladiratuzumab vedotin, which has reached the phase II stage for breast cancer and other solid tumors. The second deal gives Merck an exclusive license to commercialize the small-molecule tyrosine kinase inhibitor Tukysa (tucatinib) in Asia, the Middle East and Latin America and other regions. Tukysa was approved by the FDA in April for advanced unresectable or metastatic HER2-positive breast cancer.

Charmless: Third CRL for Mallinckrodt’s terlipressin

Mallinckrodt plc’s decade-long frustration with getting approval for terlipressin, its vasopressin analogue selective for V1 receptors, continues as the FDA issued the company a third complete response letter for the drug. According to Mallinckrodt, of Staines-upon-Thames, U.K., the FDA said it cannot approve terlipressin’s NDA in its current form and that it requires more information supporting a positive risk-benefit profile. Terlipressin, aimed at treating adults with hepatorenal syndrome type 1, had a Sept. 12 PDUFA that came and went over the weekend. In midday trading, the company’s stock (NYSE:MNK) sagged 6% at $1.12 per share.

Cassava turns bitter phase IIb readout sweet with updated biomarker data

A new analysis of biomarkers, superseding initially inexplicable results released in May, appears to have re-ignited enthusiasm for the experimental Alzheimer’s disease (AD) candidate, sumifilam, the lead development candidate at Texas-based Cassava Sciences Inc. Compared to a placebo, participants treated in the phase IIb trial with the filamin A modulator saw "significantly improved" biomarkers of AD as well as cognitive improvements, the company said. Shares (NASDAQ:SAVA) rose 88.9% by midday.

Neogene’s $110M series A for individualized TCR approach in cancer

LONDON – Neogene Therapeutics BV has raised $110 million in a series A round to advance development of a novel T-cell immunotherapy for treating solid tumors. The company has a high-throughput technology platform for isolating and sequencing T-cell receptors (TCRs) from neoantigens in standard tumor biopsies and engineering those sequences into autologous T cells, before re-administration to the patient. The resulting products will stand at the intersection of CAR T and cell therapies, said Carsten Linnemann, co-founder and CEO of Neogene.

Biopharma companies utilizing artificial intelligence for drug research

Biopharma companies are relying more and more on artificial intelligence and machine learning (AI/ML) to help them uncover the intricacies of disease mechanisms and open up strategies to develop novel medicines for treatment. As a result, the BioWorld Artificial Intelligence price-weighted index, which includes biopharmaceutical companies, medical devices and health care services companies has climbed in value and is currently up almost 37% in value year-to-date.

‘Most favored nation’ pricing: Empty gesture? Or a sign of things to come?

Ignoring industry’s threat of a lawsuit, U.S. President Donald Trump is moving forward with his plan for “most favored nation” pricing of certain prescription drugs. The president, on Sept. 13, signed the executive order he threatened in July for Part B drugs, plus an accompanying order that includes Part D drugs. In doing so, he rejected biopharma’s counter offer last month of a voluntary program in which drug companies would offer participating hospitals a discount on Part B drugs administered to both inpatients and outpatients. Coming so late in Trump’s term, the executive orders are being seen by many as an empty political gesture, given the threatened court challenges and the long process of putting such a plan into place.

Australia’s Clinuvel expands R&D presence as it builds out pipeline for DNA repair

PERTH, Australia – With the launch of its lead product, Scenesse (afamelanotide), in the U.S. and Europe, Melbourne-based Clinuvel Pharmaceuticals Ltd. is expanding its global footprint and widening its pipeline as it opens a new R&D center in Singapore and builds up its franchise in photo medicine. What sets Clinuvel apart is its old-fashioned approach to handling all activities in-house and its single focus on one drug.

Canbridge wins approval for MPS II drug and expands partnership with UMass

BEIJING – Canbridge Pharmaceuticals Inc. last week won marketing approval in China for its first rare disease drug, the mucopolysaccharidosis II therapy Hunterase (idursulfase beta injection). The win arrived just a day after it expanded its partnership with the University of Massachusetts Medical School to strengthen its R&D efforts in gene therapy with an aim to expand its pipeline. The moves further consolidated the company’s rare diseases presence in China.

Celltrion advancing COVID-19 antibody treatment CT-P59 and trials continue

HONG KONG – Interim results of a phase I study CT-P59, an anti-COVID-19 monoclonal antibody being developed by Incheon, South Korea-based Celltrion Inc., have confirmed the candidate’s safety, tolerability and pharmacokinetics in healthy subjects, giving the company confidence to ramp up production of the experimental antiviral.

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