Lex Commentary

Real-time commentary on markets, companies, policy, geopolitics, and investor sentiment.

[Lex Commentary @LexCommentaryEN]

$BBIO’s Attruby was linked to a 34% lower risk of clinical worsening than tafamidis in a real-world head-to-head ATTR-CM study.

The findings come as patients and doctors increasingly have more treatment options in a rapidly evolving ATTR-CM market.

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$LLY struck a deal with China’s InnoCare worth up to $3.35bn across five drug targets, including $100m in upfront and near-term payments.

Another sign Big Pharma continues to tap Chinese biotech for new medicines, even as US-China tensions put the sector under scrutiny.

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$ALNY had sought FDA approval to expand Onpattro into ATTR-CM after Phase 3 data showed benefits in function and quality of life.

More recently, Alnylam faced FDA scrutiny over misleading marketing claims for its ATTR-CM drug Amvuttra.

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ADARx Pharmaceuticals is targeting a valuation of up to $1.74bn in its US IPO, seeking to raise up to $372m.

$ABBV plans to invest up to $100m alongside the offering, while ADARx is set to list on Nasdaq under $ADRX.

[Lex Commentary @LexCommentaryEN]

$NVO outlined plans for several new blockbuster drugs as it prepared for Ozempic and Wegovy patent expirations.

Shares fell around 8% as investors questioned whether its pipeline could deliver enough growth to offset future patent pressure.

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A recent paper questioned safety monitoring in $PFE’s Covid vaccine trial, focusing partly on deaths recorded during follow-up.

FDA data showed 21 deaths among vaccine recipients and 17 among placebo recipients, but regulators said none were considered vaccine-related.

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Since 2018, $LLY and $NVO paid over $270m to more than 250,000 US doctors and prescribers to promote GLP-1 drugs, according to a Washington Post analysis.

The companies defended the spending as legitimate medical education, while critics raised conflict-of-interest concerns.

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$BBIO granted 63,009 RSUs to 36 new hires under Nasdaq rules, highlighting continued expansion.

The move came as BridgeBio built momentum in ATTR-CM with Attruby, while its $13bn market cap reflected its growing biotech presence.

[Lex Commentary @LexCommentaryEN]

A BioCentury analysis found major drugmakers increasingly looked outside their own labs for new technologies.

Recent dealmaking focused on emerging platforms including bispecifics, in vivo CAR-T, siRNA and protein degraders as pharma sought its next generation of medicines.

[Lex Commentary @LexCommentaryEN]

In June, $GLAND posted a strong quarter, with net profit up 47% to Rs 317 crore as sales rose 20% to Rs 1,800 crore.

Its CDMO business emerged as a key growth driver, while improving margins showed stronger profitability alongside rising revenue.

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Russia opened antitrust cases against $TEVA and Grotex over claims they launched generic versions of $PFE and $BMY’s Eliquis before its patent expired.

The regulator will examine whether the early launch of apixaban generics amounted to unfair competition.

[Lex Commentary @LexCommentaryEN]

When Bank of America lifted its $NAMS stake 84% to around $27m, institutions held nearly 90% of the biotech.

NewAmsterdam remained clinical-stage with minimal revenue and steep losses, while insiders had sold about $6.7m of shares over 90 days.

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The big three PBMs lost ground, with employer use falling from 63% to 54% in a year.

Express Scripts ($CI), CVS Caremark ($CVS) and OptumRx ($UNH) still held major clients, but pricing scrutiny and growing interest in alternatives pointed to a shifting market.

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The FDA recently closed its inspection of $AUROPHARMA’s Raleigh plant with a VAI classification after previously issuing 11 observations.

The closure cleared a regulatory hurdle as Aurobindo pursued FDA approval for inhalers and other products made at the site.

[Lex Commentary @LexCommentaryEN]

The AI-enabled pharma supply-chain market was projected to grow from $1.1bn in 2025 to $2.23bn by 2030, around 15% annually.

AI is increasingly being used for demand forecasting, inventory and shipment tracking as biologics make supply chains more complex.

[Lex Commentary @LexCommentaryEN]

FDA scrutiny of pharma marketing widened, with $TVTX challenged over Filspari claims, $ALNY over Amvuttra efficacy messaging and $LLY over Zepbound and Mounjaro promotions.

The actions highlighted tighter oversight of how drug benefits and risks are advertised.

[Lex Commentary @LexCommentaryEN]

Pharma job cuts continued, with Takeda planning around 4,500 reductions, $BNTX shedding 1,860 roles and $VTRS cutting roughly 10% of its workforce.

Patent cliffs, pricing pressure and a difficult funding environment continued to drive industry cost reductions.

[Lex Commentary @LexCommentaryEN]

Indian drugmakers including $SUNPHARMA, $DRREDDY, $CIPLA and $LUPIN increased their focus on Brazil as US generic margins remained pressured.

Patent expirations, including semaglutide, created new opportunities in one of the industry’s key emerging markets.

[Lex Commentary @LexCommentaryEN]

CVS Caremark ($CVS) recently reached an FTC settlement over allegations its rebate practices contributed to inflated insulin list prices.

The FTC said required changes could generate up to $8.5bn in consumer savings over 10 years, plus $4.5bn through point-of-sale rebates.

[Lex Commentary @LexCommentaryEN]

A study of 1,000+ patients found those staying on low doses of $LLY tirzepatide or $NVO semaglutide lost 5.5% and 2.2% at one year.

That compared with 20.2% and 13.7% at maintenance doses, highlighting the efficacy trade-off from remaining on starter doses.