2024 Pharma Highlights: From Regulatory Milestones to Nobel Prize-Winning Advancements

As the winter holidays approach, there's a sense of both reflection and excitement in the air. While we wrap up the year with final tasks and celebrations, the pharmaceutical industry is already setting the stage for 2025.??

Now is the perfect time to look back at the defining moments of 2024 in pharma. This year brought groundbreaking advancements, pivotal regulatory decisions, and innovative strategies that will continue to shape healthcare for years to come.??

Let’s dive into the developments driving pharma forward as we enter the new year!?

Top 10 most anticipated drug launches of 2024?

Let’s begin with the most highly anticipated drug launches discussed in January of this year and take a closer look at how they unfolded.?

#1 KarXT (Cobenfy)??

Cobenfy’s journey began with Karuna Therapeutics, a biotech punching well above its weight. When the FDA approved it in September for adult schizophrenia, it marked a breakthrough — targeting brain receptors to reduce symptoms without side effects like drowsiness. This approval was pivotal for Bristol Myers Squibb, which had acquired Karuna earlier in the year for $14 billion. By October, the drug was set to hit U.S. markets, signaling the start of its ambitious commercial rollout.?

#2 Donanemab (Kisunla)?

Donanemab’s road to approval wasn’t smooth. Initially rejected by the FDA in early 2023 due to trial issues, Eli Lilly regrouped and presented new data. Their perseverance paid off in July 2024 when the FDA approved the drug for early Alzheimer’s stages. The data showed a 35% reduction in cognitive decline, outpacing competitors. Despite earlier setbacks, Lilly emerged stronger, placing Kisunla at the forefront of Alzheimer’s innovation.?

#3 Resmetirom (Rezdiffra)?

After decades of failed attempts in the NASH field, Madrigal Pharmaceuticals delivered a win with Resmetirom. The FDA granted priority review, culminating in its March 2024 approval. This decision followed groundbreaking phase 3 data showing significant reductions in liver fat and inflammation. For a disease long considered untreatable, Resmetirom’s approval is a turning point that could revive interest in the NASH market.?

#4 Sotatercept (WINREVAIR)?

Merck’s sotatercept had been on the FDA radar for years, but delays pushed its PDUFA date to March 2024. Finally approved, WINREVAIR became the first activin signaling inhibitor for pulmonary arterial hypertension (PAH). By addressing the underlying causes of the disease rather than merely managing symptoms, Merck secured a landmark approval that redefines PAH treatment.?

#5 Datopotamab deruxtecan (Dato-DXd)?

Dato-DXd’s journey to FDA Breakthrough Therapy Designation in December 2024 was marked by hurdles. Early safety concerns and mixed survival data led AstraZeneca and Daiichi Sankyo to narrow their focus to EGFR-mutated non-small cell lung cancer (NSCLC). This refined strategy paid off, paving the way for an official approval and setting the stage for further advancements in antibody-drug conjugates.?

#6 Acoramidis (Attruby)?

BridgeBio Pharma’s acoramidis made waves with its November 2024 FDA approval for transthyretin amyloid cardiomyopathy (ATTR-CM). The approval was backed by stellar phase 3 data, showcasing a 30% reduction in cardiovascular-related deaths. BridgeBio’s partnership with Bayer for European commercialization further cements Attruby’s position as a key player in this field.?

#7 mRNA-1345 (mRESVIA)?

Moderna’s RSV vaccine for adults over 60 breezed through FDA review, earning its approval in May 2024. Its safety profile — free from links to Guillain-Barré syndrome — gave it an edge over competitors. While its international rollout faces strategic challenges, mRESVIA represents another milestone for mRNA technology in vaccines.?

#8 Anktiva?

ImmunityBio’s Anktiva achieved FDA approval in April 2024 for BCG-unresponsive non-muscle invasive bladder cancer (NMIBC). This marked the culmination of rigorous trials, with a 71% complete response rate and durability data that outperformed competitors. The approval offers new hope for patients facing invasive treatments like bladder removal.?

#9 Ensifentrine (Ohtuvayre)?

Verona Pharma’s ensifentrine secured FDA approval in June 2024 for COPD maintenance therapy. Backed by a strategic focus on high-prescribing physicians and omnichannel campaigns, Verona is setting the stage for strong adoption in a competitive market.?

#10 Imetelstat (Rytelo)?

Geron’s imetelstat capped the year with its June 2024 FDA approval as the first telomerase inhibitor for transfusion-dependent anemia in myelodysplastic syndromes (MDS). This milestone came after decades of research, with pivotal trial data demonstrating significant transfusion independence. Geron’s persistence has paid off, setting a new standard in hematology.?

Each approval this year tells a story of innovation, persistence, and breakthroughs, marking 2024 as a defining year in pharma history. Which of these milestones inspires you most??

Why pharma companies are changing their names?

?It turns out 2024 was quite the year for company makeovers, with several big players deciding to switch up their names to showcase their redefined missions and expanded horizons.?

One of the year’s headline moves came from Johnson & Johnson, which renamed its pharmaceutical arm Johnson & Johnson Innovative Medicine. This shift isn’t just cosmetic, it highlights a sharpened focus on tackling some of medicine’s toughest challenges, including oncology, immunology, and neuroscience.?

BeiGene transformed into BeOne Medicines as they've grown beyond their Chinese roots and are making waves in cancer treatment, especially with their successful blood cancer drug Brukinsa.?

Vaccitech became Barinthus Biotherapeutics because, despite their fame from co-inventing AstraZeneca's COVID vaccine, they're actually doing much more than just vaccines. The name “Barinthus,” inspired by a mythical guide in Arthurian legend, reflects its vision of directing the immune system to heal.?

Cullinan Oncology, meanwhile, has subtly evolved into Cullinan Therapeutics. This change mirrors its broader ambitions, as the company pivots from an exclusive focus on cancer to explore autoimmune diseases, including lupus. The new name embodies its intent to expand therapeutic offerings while maintaining its oncology expertise.?

Finally, Eliem Therapeutics rebranded as Climb Bio after acquiring Tenet Medicines and shifting its focus to immune-mediated diseases. The new name represents the challenges faced by patients and the effort required to develop meaningful treatments, symbolizing an upward journey toward better outcomes.?

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Racing for drug innovation: Leading pharma companies by number of originated drugs in 2024?

In a striking shift that's turning heads across the pharmaceutical landscape, Chinese pharmaceutical giant Jiangsu Hengrui has emerged as the global leader in originated drugs, boasting an impressive portfolio of 138 medications. This marks a significant changing of the guard in an industry traditionally dominated by Western pharmaceutical companies.?

The numbers tell a compelling story: Hengrui has edged past industry stalwarts Pfizer (127 drugs) and Roche (125 drugs), while fellow Chinese company Sino Biopharmaceutical maintains a strong position with 84 drugs in its arsenal. This East-West dynamic adds an intriguing layer to the global pharmaceutical race, particularly as companies vie for dominance in emerging markets.?

Perhaps most surprising is the relative positioning of some industry veterans. Johnson & Johnson, despite its recent rebranding to emphasize innovative medicine, sits at 81 originated drugs, while Merck & Co. and Bayer round out the bottom of our top 15 with 69 and 61 drugs respectively.?

Are we witnessing a permanent shift in pharmaceutical R&D leadership? How will Western pharma giants respond to this Eastern challenge? As 2024 unfolds, these questions will likely shape strategic decisions across the industry.?

The protein puzzle or how Machine Learning won the Nobel Prize?

2024 has brought us something truly revolutionary. The scientific world long grappled with a fundamental mystery: how do proteins fold themselves into their precise shapes? Well, that puzzle has finally been cracked, and it earned three brilliant minds the Nobel Prize in Chemistry.?

Think of proteins as tiny molecular origami – they need to fold just right to work properly. When they don't, we end up with diseases like Alzheimer's or diabetes. For years, scientists were essentially trying to predict how a piece of paper would fold without being able to touch it. Pretty tricky!?

The three Nobel laureates, Demis Hassabis and John Jumper from DeepMind, and David Baker from the University of Washington, did something remarkable — they taught AI to predict protein shapes with incredible accuracy.?

What makes this particularly exciting for the pharmaceutical industry is DeepMind's latest creation, AlphaFold3. Released this year, it doesn't just predict protein shapes — it can spot where drugs might bind to these proteins. This is huge for drug development, potentially making the process faster and more precise than ever before.?

And here's an interesting twist: this marks one of the rare times the Nobel Prize in Chemistry has gone to research from a tech company rather than academia. Google's DeepMind is now venturing into drug development through their new company, Isomorphic Labs, suggesting we might be seeing more tech-pharma collaborations in the future.?

How the shingles vaccine might protect your brain?

?A recent article in Nature Medicine shares some exciting news about the recombinant shingles vaccine (RZV). Researchers from the University of Oxford found that getting this vaccine might do more than just protect you from shingles — it could lower your risk of dementia.?

The study looked at a large amount of population data and discovered that people who received the shingles vaccine had a noticeably lower chance of developing dementia compared to those who didn’t.??

The exact reasons why the shingles vaccine might protect against dementia aren't fully understood. One theory is that the vaccine protects against herpes infections, which have been linked to dementia for years, though this connection is still debated. Another possibility is that the recombinant vaccine contains immune-boosting ingredients that may play a role in protecting against dementia.?

This finding opens up an interesting possibility: vaccines could play a bigger role in preventing conditions like dementia. Of course, more research is needed to fully understand what’s going on, but it’s definitely a step in a good direction.?

What 2025 has in store for life sciences?

?The 2025 Life Sciences Executive Outlook from Deloitte reveals a generally optimistic perspective among global life sciences executives, with 75% expressing confidence about the upcoming year. Here’s what’s buzzing:?

• The spotlight is on digital technologies, especially generative AI, with 60% of executives keeping a close eye on it. Many are gearing up to boost their AI investments, seeing its potential for improving productivity and cutting costs, particularly in research and development.?

• Pricing and access to drugs are top concerns, with nearly half of respondents saying these will play a major role in shaping their strategies. Add to that the looming patent cliff — putting over $300 billion in sales at risk as patents expire — and it's no surprise there's a growing focus on mergers and acquisitions to navigate the challenge.?

• Executives are realizing it’s time to rethink R&D strategies as productivity continues to decline. Many are turning to AI and digital twins to speed up drug development. Interestingly, around 32% of biopharma leaders are putting innovations like cell and gene therapies ahead of traditional drug development methods.?

• Improving customer experience is a big priority, especially for biopharma companies, which are moving faster than medtech firms to adapt to changing customer needs. More and more, they're leveraging AI to deliver personalized interactions with healthcare providers and consumers.?

• Executives are voicing concerns about possible regulatory changes in the U.S. and around the world that could shake up their operations. Inflation and supply chain disruptions are still on their radar, as companies brace themselves for any unexpected challenges.?

To our wonderful team and readers?

As we close out 2024, we want to take a moment to extend our heartfelt gratitude to all the incredible people who made this year unforgettable. To our Viseven team, thank you for your hard work, creativity, and commitment to excellence. To our readers, clients, and partners, your trust and collaboration inspire us to reach new heights.?

This year has been filled with remarkable milestones in pharma, innovation, and partnerships. Together, we’ve made strides that truly matter, shaping a better future for healthcare and beyond.?

Wishing you a joyous holiday season filled with warmth, happiness, and well-deserved moments of celebration. Cheers to a bright 2025:)???

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