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India FY22 Earnings: Everyone’s Talking Of Big Spikes In Input, Logistics Costs
The sharp escalation in prices of raw materials, solvents, excipients and logistics in a volatile operating environment charged by geopolitical tensions and supply chain challenges was one of the key talking points at the fiscal fourth quarter earnings discussions of leading Indian firms. With little hope for respite any time soon, companies are devising strategies to cope.

CureVac Takes Another Shot At mRNA Vaccines, Expands Cancer Work
Its first COVID-19 vaccine failed last year, but fueled by payments from the EU, Germany and GSK, CureVac is trying again with two further versions of its mRNA platform.

Zydus Pivots To Multivariant COVID-19 Vaccine, Looks To Revlimid Opportunity
Zydus is pivoting to a multivariant version of its plasmid DNA vaccine against COVID-19, ZyCoV-D, after the original didn’t receive an encouraging response. It also looks to launch a Revlimid generic in the second wave while an opportunity might soon emerge from Takeda’s Pentasa.

Closed-Loop Inspections? Strict COVID Zero Policy Delays FDA's China Field Trips
Chinese biotechs are bracing for lengthy delays as the nation’s unwaveringly stringent restrictions continue to cause barriers to on-site inspections from the US FDA. Hard-hit domestic firms are proposing a "quarantine bubble" like that used during the Beijing Winter Olympics to put back on track the field checks necessary for obtaining biologics approvals.

Shanghai Pharma Manufacturing Halves In April
China's main pharma hub of Shanghai reported sector output has plunged by more than half due in large part to the prolonged lockdown, while 58% of surveyed foreign companies in China across all industries project declining revenue.

Coronavirus Update: Vir, WuXi Terminate COVID-19 Antibody Pact
Xevudy, which was part of the deal, has already seen restrictions on its use due to diminished efficacy against Omicron. Plus, Ocugen is back in the game as the FDA has released the clinical hold on its Phase II/III vaccine trial, while Pfizer/BioNTech release new booster shot data for Comirnaty in children aged 6 months-5 years.

Dr Reddy’s Pressing On In Russia, China Approvals Add Spark
Momentum for Dr Reddy’s in China as a string of approvals including for lenalidomide come through, while it appears to be on an even keel in Russia, a market where several foreign firms have cutback activities in the wake of the Ukraine conflict. Will the Indian firm’s Russia strategy payback?

Homegrown China Oral Antiviral Shows Early Promise
Junshi’s oral antiviral shows signs of effectiveness in treating patients with mild COVID-19 symptoms but more data are needed, caution researchers.

Russia-Ukraine War Likely To Claim Sputnik V Partners As Casualty
In light of the Russia-Ukraine conflict, Scrip looks at data to gauge if manufacturing partners for COVID-19 vaccine Sputnik V or Light, in India, China and Korea could be left holding unsold inventory earmarked for exports

AstraZeneca Buys Into COVID-19 Antibodies From Newly Launched RQ Bio
The big pharma company and its new partner both expect demand to continue for pre-exposure prophylaxis antibody therapies, for COVID-19 and beyond.

Valneva Hits New COVID-19 Jab Low With EC Contract Termination
Less than a year after signing a major advance purchase agreement to supply its inactivated COVID-19 jab to the EU, Valneva is faced with a termination that could hit its 2022 guidance.

Stock Watch: One Acquisition Does Not Make A Biotech M&A Boom
Another blow-out quarter from Pfizer provided the impetus for an acquisition. But the history of recent commercial-stage biotech transactions and the risky nature of all early-stage companies suggest that the floodgates will not burst open.

COVID-19 Vaccine Trial Efficiencies, Leadership Alignment: What Can Be Carried Forward
Operational actions, organizational responses and clinical development model improvements led to a 26-month acceleration, on average, in a set of COVID-19 vaccine pivotal trials versus similarly sized pre-pandemic studies, with the database lock and analysis stage delivering dramatic gains, a study by IQVIA Institute indicates. Can these benefits be recapitulated across the portfolio in the post-pandemic era?

How Ex-Janssen India Chief Is Steering Bharat Serums’ Ambitions In Women’s Health
Sanjiv Navangul, managing director and CEO, Bharat Serums and Vaccines, in a wide-ranging interview with Scrip, outlines the firm’s game plan to establish itself as a “force to reckon with” in women’s health - it goes beyond drugs and encompasses devices and potentially digital therapeutics as well. The former Janssen India chief also weighs in on the worrying industry-wide input cost escalation scenario and supply chain turbulence.

COVID-19 Relapses, Lack Of Omicron Data Complicate Paxlovid Case In India
A few cases of COVID-19 relapse have Twitter abuzz about the need for data on Paxlovid’s effectiveness, particularly against the Omicron variant and in vaccinated individuals. Despite regulatory approval in India, the drug has not yet been included in treatment guidelines and a debate on recommended dosage now complicates matters

Merck KGaA Well-Equipped Against War And Raw Material Shortages
Despite the impact of the war in Ukraine and spiralling costs, as well as lower COVID-19-based revenues, the German group is forecasting a healthy financial performance for full-year 2022.
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