In this edition
Tuesday: KalVista HAE approval; Trump signs tax law; EU life sciences strategy
Thursday: Merck buys Verona; Gilead HIV access deal; ProKidney kidney therapy
Friday: FDA publishes rejection letters; AbbVie trispecific deal
Monday 7 July
China moved to shut EU companies out of its government procurement of medical devices, answering the block Brussels imposed three weeks earlier.
China’s Ministry of Finance said that from 6 July, where a public buyer has a budget above 45 million yuan (about $6.3 million) and needs imported devices, EU firms are to be excluded, other than EU-owned companies based in China. Where non-EU suppliers are used instead, EU-made devices may not exceed half the contract value.
The measure mirrors the European Commission’s decision on 20 June to bar Chinese firms from EU medical device tenders worth more than €5 million, taken under the International Procurement Instrument. Beijing exempts contracts that only EU-imported devices can fulfil, matching a carve-out in the EU measure. Device procurement is now a two-way front in the EU-China trade dispute.
Sources:
China to take measures against medical devices imported from EU in government procurement - The State Council of the People’s Republic of China
Tuesday 8 July
The FDA approved KalVista’s EKTERLY, the first oral on-demand treatment for hereditary angioedema.
Sebetralstat, a plasma kallikrein inhibitor, is cleared for acute attacks in patients aged 12 and over. Hereditary angioedema causes sudden, potentially life-threatening swelling, and the existing on-demand treatments are injected or infused, so a pill changes how an attack is handled. Approval rested on the Phase 3 KONFIDENT trial, which KalVista calls the largest study run in the disease, where the drug cut the time to the start of symptom relief and to complete resolution against placebo.
The approval landed after KalVista’s June target date, which the company put down to capacity constraints at the FDA. KalVista said it learned only afterwards that FDA Commissioner Marty Makary had briefly and unsuccessfully pressed reviewers to reject the drug.
Sources:
KalVista Pharmaceuticals announces FDA approval of EKTERLY (sebetralstat) - KalVista Pharmaceuticals
KalVista CEO talks FDA drug approval review delay - Endpoints News
President Trump signed his tax and spending bill, the One Big Beautiful Bill Act, into law on 4 July.
The Act carries the core of his second-term domestic agenda. It makes the 2017 tax cuts permanent and adds new tax measures, alongside spending reductions that include cuts to federal Medicaid. The Senate passed it 51 to 50 on 1 July, with the Vice President breaking the tie, and the House 218 to 214 on 3 July.
Sources:
President Trump’s One Big Beautiful Bill is now the law - The White House
The European Commission launched a life sciences strategy meant to close the gap with the United States and China.
Published on 2 July, “Choose Europe for Life Sciences” sets a goal of making the EU the most attractive place in the world for the sector by 2030, and points to Europe’s failure to turn its research strength into products on the market. It is built around three areas: easier funding for research and multi-country clinical trials, a proposed EU Biotech Act to smooth market access, and €300 million to prime public procurement of life-science innovation. The Commission puts the sector’s contribution at nearly €1.5 trillion of value and 29 million jobs across the EU.
Sources:
Making Europe a global leader in life sciences - European Commission
Wednesday 9 July
President Trump said he would put tariffs of up to 200% on pharmaceuticals imported into the United States.
Speaking at a cabinet meeting on 8 July, he said the levies would come “very soon” but not straight away, giving drugmakers about a year to 18 months to move production to the US before they applied. Commerce Secretary Howard Lutnick said details would follow at the end of the month. The industry has been waiting for a decision since the Section 232 national-security investigation into pharmaceutical imports opened in April.
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Thursday 10 July
Merck agreed to buy Verona Pharma, the London-founded respiratory biotech, for about $10 billion.
The definitive agreement, announced on 9 July after talks reported earlier in the week, values Verona at $107 per American depositary share. It gives Merck Ohtuvayre (ensifentrine), a first-in-class inhaled treatment for chronic obstructive pulmonary disease that the FDA approved in 2024. It is one of the largest takeovers of a UK-founded biotech.
The deal is structured as a scheme of arrangement under UK law and was expected to close in the fourth quarter of 2025.
Sources:
Merck to acquire Verona Pharma - Merck
Gilead finalised a deal to supply its twice-yearly HIV prevention drug lenacapavir to up to two million people in lower-income countries.
The Global Fund will buy and distribute the doses over three years, and Gilead will provide them at no profit until royalty-free generic versions reach the market. Lenacapavir, an HIV capsid inhibitor sold in the US as Yeztugo, was approved there for pre-exposure prophylaxis in June. This is the first large access agreement for it, and Gilead casts the deal as bringing the injection to poorer countries at the same time as wealthy ones rather than years later.
Sources:
Gilead finalizes agreement with the Global Fund on twice-yearly lenacapavir for HIV prevention - Gilead Sciences
ProKidney reported positive Phase 2 results for its kidney cell therapy and set course for accelerated approval.
In the REGEN-007 trial, rilparencel, an autologous cell therapy made from a patient’s own kidney cells, slowed the annual decline in kidney function by 78% in the main patient group, from -5.8 to -1.3 mL/min/1.73m2, a statistically significant difference, with no treatment-related serious adverse events. ProKidney said the FDA had accepted eGFR slope as a surrogate endpoint and that its Phase 3 PROACT 1 trial could support both accelerated and confirmatory approval.
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Friday 11 July
The FDA published more than 200 complete response letters, the rejection notices it normally keeps private.
A complete response letter is what the agency sends a company when it will not approve a drug or biologic as submitted. Firms that receive one often say little about why, so the reasons have stayed out of public view. The batch released covers applications from 2020 to 2024, and the FDA cast it as part of a wider transparency drive, giving investors and rivals a direct look at the deficiencies it most often cites.
Sources:
AbbVie licensed a trispecific antibody for multiple myeloma from Ichnos Glenmark Innovation in a deal worth up to $1.925 billion.
AbbVie pays $700 million upfront, up to $1.225 billion in milestones and tiered double-digit royalties. ISB 2001, built on the partner’s BEAT platform, is a T-cell engager that grips BCMA and CD38 on myeloma cells and CD3 on T cells, and is in a Phase 1 trial for relapsed or refractory disease with US orphan drug and fast track status. Ichnos Glenmark Innovation is the innovation arm of India’s Glenmark Pharmaceuticals, and early data across 35 patients showed a 79% response rate. AbbVie takes rights across North America, Europe, Japan and Greater China.
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